Clinical trial • Phase III • Ophthalmology
Aflibercept for Neovascular age-related macular degeneration
Phase III trial of Aflibercept for Neovascular age-related macular degeneration.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Neovascular age-related macular degeneration
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme|Gene therapy|Small molecule
Key dates
- Initial CTIS Submission Date
- 13-06-2025
- First CTIS Authorization Date
- 21-11-2025
Trial design
Randomised, aflibercept (eylea) 2 mg intravitreal injection every 8 weeks (q8w) as the active-controlled comparator; investigational arm: single intravitreal injection of 4d-150 (3 ×10^10 vector genomes [vg]). Phase III trial in Bulgaria, France, Germany and others.
- Randomised
- Yes
- Comparator
- Aflibercept (Eylea) 2 mg intravitreal injection every 8 weeks (Q8W) as the active-controlled comparator; investigational arm: single intravitreal injection of 4D-150 (3 ×10^10 vector genomes [vg]).
- Target Sample Size
- 182
- Trial Duration For Participant
- 728
Eligibility
Recruits 182 No vulnerable populations selected. Participants must provide signed informed consent prior to any protocol-specific assessments ("Signed informed consent before any protocol-specific assessment is performed"). Trial enrols adults (≥50 years); no assent/parental consent provisions described..
- Pregnancy Exclusion
- Female of child-bearing potential, per (CTFG, 2020).
- Vulnerable Population
- No vulnerable populations selected. Participants must provide signed informed consent prior to any protocol-specific assessments ("Signed informed consent before any protocol-specific assessment is performed"). Trial enrols adults (≥50 years); no assent/parental consent provisions described.
Inclusion criteria
- {"criterion_text":"- Signed informed consent before any protocol-specific assessment is performed\n- Ability to comply with the protocol-specified procedures and visits, in the Investigator’s judgment\n- ≥50 years of age at time of consent\n- Agree to use a barrier method (e.g. condom) during intercourse for 3 months after Day 1 to prevent fluid transmission; sexually active males should not father a child or donate sperm during this period.\n- MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: a. Treatment naïve, i.e. no prior IVT anti-VEGF therapy, OR b. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND Documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator\n- Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center\n- MNV lesion in the study eye of any type (i.e. predominantly classic, minimally classic, or occult [including polypoidal choroidal vasculopathy and retinal angiomatous proliferation]) at the Screening Visit, confirmed by the Reading Center, which exhibits all of the following characteristics: a. Total lesion size of 9 disc areas or less (inclusive of blood, fibrosis, atrophy or neovascularization) on FA b. MNV component area at least 50% of total lesion size on FA c. MNV exudation (i.e. presence of fluid) on SD-OCT\n- CST ≤500μm in the study eye at Screening visit, confirmed by the Reading Center\n- Demonstrated clinical response to aflibercept and functional stability in the study eye: a. From Week −5 to Week −1: a ≥ 15% reduction in CST or complete resolution of IRF and/or SRF, determined by SD-OCT and confirmed by the Reading Center b. At Day 1: BCVA measurement must not have decreased by 15 ETDRS letters or more compared to BCVA at the Screening visit\n- BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit\n- BCVA ≥34 ETDRS letters (~20/200 Snellen equivalent) in the contralateral eye at the Screening Visit\n- Study eye amenable to IVT injection identified by the Investigator prior to Week −5"}
Exclusion criteria
- {"criterion_text":"- Ocular Conditions: a. MNV due to causes other than nAMD in either eye b. Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter), retinal pigment epithelial tear, macular hole, vitreomacular traction, Stargardt disease, drug induced maculopathies, macular edema not due to nAMD, or retinal neovascular occlusion, in the study eye as determined by the Reading Center at the Screening Visit c. History of retinal detachment in the study eye d. Any active ocular inflammation or active ocular or periocular infection in either eye (e.g. infectious blepharoconjunctivitis) at any time between the Screening Visit and Randomization. e. History of intraocular inflammation (e.g. endophthalmitis), or uveitis in either eye, or presence of any cells or flare in the anterior chamber or any cells or haze in the vitreous in the study eye at any time prior to Randomization. f. History of latent ocular or periocular infection (e.g. ocular syphilis, herpetic eye disease) g. History of steroid-induced ocular hypertension or steroid-induced glaucoma in either eye h. Intraocular pressure (IOP) <6 mmHg (by Goldmann tonometry) in the study eye i. Any history of ocular hypotony or ciliary body dysfunction/pathology in either eye as determined by the Investigator j. Glaucoma or intraocular hypertension requiring more than 2 topical medications for control (defined as IOP <22 mm Hg) in the study eye k. Any other pre-existing eye conditions or surgical complications that in the opinion of the Investigator would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints."}
- {"criterion_text":"- Ocular Treatments/Interventions in the Study Eye: a. Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF, including, but not restricted to IVT therapy (e.g. steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention b. Aphakia, pseudophakia with anterior chamber intraocular lens, or significant violation of the posterior capsule, with the exception of yttrium-aluminum garnet (YAG) with posterior chamber lens implantation c. History of the following surgeries and procedures: cataract surgery associated with complications, incisional glaucoma surgery (e.g. trabeculectomy), glaucoma tube or shunt placement, pars plana vitrectomy, corneal transplant, sub-macular surgery, retinal detachment surgery, ranibizumab injection implant (Susvimo™), macular laser or extensive panretinal photocoagulation, radiation therapy. d. Uncomplicated cataract surgery, YAG laser posterior capsulotomy, or glaucoma laser treatment in the 3 months prior to the Screening Visit e. Any concurrent intraocular condition (e.g. amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the Investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study f. Any prior exposure to brolucizumab"}
- {"criterion_text":"- Prior/Concomitant Medications (Systemic or in Either Eye): a. Receiving or anticipated to receive a systemic drug that inhibits VEGF pathways, e.g. bevacizumab, sunitinib, pazopanib b. Ever received or anticipated to receive IVT complement inhibitors (e.g. pegcetacoplan, avacincaptad pegol) in either eye c. History of serious allergy, hypersensitivity, or contraindications to fluorescein and/or trial-specified interventions (e.g. 4D-150 excipients, aflibercept, povidone-iodine)"}
- {"criterion_text":"- Prior Interventional Trial Participation: a. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months or at least 5 half-lives (whichever is longer) prior to Screening b. Any prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy"}
- {"criterion_text":"- Systemic Conditions and Considerations: a. Major illness or major surgical procedure in the 28 days prior to the Screening Visit b. Uncontrolled blood pressure, defined as resting average systolic value ≥160 mmHg and/or average diastolic value ≥100 mmHg, based on triplicate measurements at 1-minute intervals at Screening. If blood pressure exceeds these values, measurements can be repeated up to 3 times within the Screening Visit window. Blood pressure medications should be at stable dose/regimen for at least 28 days prior to Screening. c. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit d. Any history of syphilis (whether or not treated) e. History of autoimmune condition that may predispose to the development of uveitis, including, but not limited to Behcet disease, spondyloarthropathies, multiple sclerosis, HLA-B27 syndrome, Crohn’s disease, sarcoidosis, lupus, or rheumatoid arthritis f. Any documented active or suspected malignancy, or history of malignancy within 12 months prior to Screening, except appropriately treated/resected localized tumor with low risk for recurrence (e.g. treated local basal cell or squamous cell carcinoma of the skin, noninvasive bladder cancer, prostate cancer stage 1 or 2 with stable prostate-specific antigen for 6 months, or any cancer considered surgically cured) g. Intercurrent illness or condition that, in the opinion of the Investigator, may place the subject at an unacceptable risk, prevent the subject from completing the trial, or confound interpretation of trial results h. Female of child-bearing potential, per (CTFG, 2020)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Mean change from baseline in BCVA ETDRS letter score at Week 52","definition_or_measurement_approach":"Mean change in best-corrected visual acuity (BCVA) measured by ETDRS letter score from baseline to Week 52; primary efficacy comparison is non-inferiority of 4D-150 versus aflibercept."}
Secondary endpoints
- {"endpoint_text":"- Mean annualized number of aflibercept injections after Week 4 through Weeks 52 and 104","definition_or_measurement_approach":"Annualized count of aflibercept intravitreal injections administered after Week 4, evaluated through Weeks 52 and 104."}
- {"endpoint_text":"- Incidence and timing of aflibercept injections after Week 4 through Weeks 52 and 104","definition_or_measurement_approach":"Incidence and timing (time-to-event) of need for aflibercept injections post Week 4, assessed through Weeks 52 and 104."}
- {"endpoint_text":"- Proportion of subjects not requiring aflibercept injections after Week 4 through Weeks 52 and 104 in the 4D-150 arm","definition_or_measurement_approach":"Proportion of participants in the 4D-150 arm who do not require any aflibercept injections after Week 4 up to Weeks 52 and 104."}
- {"endpoint_text":"- Time to first aflibercept injection after Week 4 in the 4D-150 arm","definition_or_measurement_approach":"Time-to-first aflibercept injection following Week 4 among participants in the 4D-150 arm."}
- {"endpoint_text":"- Mean change from baseline in CST over time through Weeks 52 and 104","definition_or_measurement_approach":"Mean change from baseline in central subfield thickness (CST) measured by SD-OCT over time through Weeks 52 and 104."}
- {"endpoint_text":"- Mean change from baseline in BCVA ETDRS letter score over time through Weeks 52 and 104","definition_or_measurement_approach":"Mean change from baseline in BCVA (ETDRS letters) assessed longitudinally through Weeks 52 and 104."}
Recruitment
- Digital Remote Recruitment
- True, PatientGO digital app and associated PatientGO Data Consent forms and App EULA are used for patient information, consent/data-consent workflows and participant engagement across participating countries.
- Planned Sample Size
- 182
- Recruitment Window Months
- 37
- Consent Approach
- Informed consent is obtained by signed informed consent prior to any protocol-specific assessments ("Signed informed consent before any protocol-specific assessment is performed"). ICFs and subject information sheets are provided in multiple languages (documents available in English, Bulgarian, Spanish, French, Italian, Portuguese, Hungarian, Lithuanian, Latvian, Russian and others as indicated by L1/L2 document files). There is a specific 'Pregnant Partner' information/consent document. Participants are adults (≥50 years); no assent or parental consent provisions are described.
Methods
- Doctor-to-doctor letters (K2_Recruitment material_Dr to Dr Letter files present in multiple languages) — channel: direct HCP communication; target audience: ophthalmologists/retina specialists; country-specific materials available (e.g., Dr to Dr letter_ES, DR-to-DR in ENG/FR/IT/BUL).
- Patient brochures / patient brochure cards (K2_Recruitment material_Patient brochure and _Card in multiple languages) — channel: printed leaflets handed out at clinics; target audience: potential patient participants; country-specific language versions available (ENG, BUL, ES, FR, IT, LAV, etc.).
- Posters (K2_Recruitment material_Poster files) — channel: site-based advertising (clinic posters); target audience: patients attending ophthalmology clinics; country-specific language versions available.
- Participant journey / patient information materials (Participant journey documents, Patient brochures, SIS and ICF documents) — channel: site-based and take-home materials explaining study flow; target audience: eligible patients at participating sites; localized per country/language.
- PatientGO digital platform (PatientGO App, EULA, PatientGO Patient Info Sheet) — channel: digital/mobile app for participant information, scheduling, data consent and engagement; target audience: potential and enrolled participants across multiple countries.
- Appointment reminder cards and Subject ID cards — channel: printed materials provided to participants by sites to support retention and visit attendance.
- Comfort / appreciation items and reimbursement information (comfort_items, Payment Card Letter, Travel and Reimb Policy) — channel: site-provided items and reimbursement policies to support participation and retention.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 298
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 224
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- MBAL Trakia EOOD
- Department Name
- Ophthalmology Diseases Department
- Contact Person Name
- Valentin Hristozov
- Contact Person Email
- drhristozov@gmail.com
- Site Name
- Military Medical Academy
- Department Name
- Clinic of Eye Diseases
- Contact Person Name
- Hristina Vidinova
- Contact Person Email
- christinavidinova@yahoo.com
- Site Name
- Specialized Hospital For Active Treatment Of Eye Diseases Zora OOD
- Department Name
- Department – eye diseases
- Contact Person Name
- Iva Petkova
- Contact Person Email
- ivapetkova@abv.bg
France
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 218
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- Institut Ophtalmologique De l'Ouest Jules Verne
- Contact Person Name
- Frank BECQUET
- Contact Person Email
- frankbecquet@yahoo.fr
- Site Name
- Centre Monticelli Paradis D Ophtalmologie
- Department Name
- Ophtalmologie
- Contact Person Name
- Francois DEVIN
- Contact Person Email
- fdbm.retine@gmail.com
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Service ophtalmologie
- Contact Person Name
- Stephanie BAILLIF
- Contact Person Email
- baillif.s@chu-nice.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 212
- Number Of Sites
- 6
- Number Of Participants
- 16
Sites
- Site Name
- Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)
- Contact Person Name
- Hakan Kaymak
- Contact Person Email
- dr.h.kaymak@gmail.com
- Site Name
- Augenzentrum Prof. Dr. Koch GmbH
- Contact Person Name
- Frank Koch
- Contact Person Email
- f.koch@azffm.de
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Universitäts-Augenklinik
- Contact Person Name
- Kristina Pfau
- Contact Person Email
- Kristina.Pfau@ukbonn.de
- Site Name
- Internationale Innovative Ophthalmochirurgie GbR (I.I.O.)
- Contact Person Name
- Hakan Kaymak
- Contact Person Email
- dr.h.kaymak@gmail.com
- Site Name
- Diakonie Klinikum Dietrich Bonhoeffer GmbH
- Contact Person Name
- Christian Karl Brinkmann
- Contact Person Email
- BrinkmannC@dbknb.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik fuer Augenheilkunde
- Contact Person Name
- Rainer Guthoff
- Contact Person Email
- Rainer.Guthoff@med.uni-duesseldorf.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 15-08-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 249
- Number Of Sites
- 8
- Number Of Participants
- 100
Sites
- Site Name
- University Of Szeged
- Department Name
- Ophthalmology
- Contact Person Name
- Edit Toth-Molnar
- Contact Person Email
- toth-molnar.edit@med.u-szeged.hu
- Site Name
- Semmelweis University
- Department Name
- Ophthalmology
- Contact Person Name
- Andras Papp
- Contact Person Email
- papp.andras1@med.semmelweis-univ.hu
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- Ophthalmology
- Contact Person Name
- Norbert Czumbel
- Contact Person Email
- czumbel@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Ophthalmology
- Contact Person Name
- Attila Vajas
- Contact Person Email
- vajasa@gmail.com
- Site Name
- Budapest Retina Associates Kft.
- Department Name
- Ophthalmology
- Contact Person Name
- Andras Seres
- Contact Person Email
- seres@budapestretina.hu
- Site Name
- Nozologen Kft.
- Department Name
- Ophthalmology
- Contact Person Name
- Balazs Varsanyi
- Contact Person Email
- varsanyi.balazs@ganglion.hu
- Site Name
- Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
- Department Name
- Ophthalmology
- Contact Person Name
- Agnes Kerenyi
- Contact Person Email
- agneskerenyi@gmail.com
- Site Name
- Budapesti Jahn Ferenc Del Pesti Korhaz Es Rendelointezet
- Department Name
- Ophthalmology
Italy
- Earliest CTIS Part Ii Submission Date
- 09-09-2025
- Latest Decision Or Authorization Date
- 21-04-2026
- Processing Time Days
- 224
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- Dipartimento di Scienze Cliniche e biomediche
- Contact Person Name
- Giovanni STAURENGHI
- Contact Person Email
- Giovanni.staurenghi@unimi.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- Medicina Sperimentale
- Contact Person Name
- Federico RICCI
- Contact Person Email
- rccfrc@gmail.com
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unita Operativa di Oculistica
- Contact Person Name
- Francesco BANDELLO
- Contact Person Email
- bandello.francesco@hsr.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Dipartimento di Medicina Sperimentale e Clinica, Clinica Oculistica
- Contact Person Name
- Marco LUPIDI
- Contact Person Email
- marco.lupidi@ospedaliriuniti.marche.it
Latvia
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 217
- Number Of Sites
- 3
- Number Of Participants
- 60
Sites
- Site Name
- Ziemelkurzemes regionala slimnica SIA
- Department Name
- Eye Centre
- Contact Person Name
- Kaspars Ozols
- Contact Person Email
- mr.kaspars.ozols@gmail.com
- Site Name
- Rigas Austrumu kliniska universitates slimnica SIA
- Department Name
- Clinical Centre "Bikernieki"
- Contact Person Name
- Kristine Baumane
- Contact Person Email
- baumanek@ml.lv
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- Ophthalmology Clinic
- Contact Person Name
- Guna Laganovska
- Contact Person Email
- glaganovska@ml.lv
Lithuania
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 17-04-2026
- Processing Time Days
- 221
- Number Of Sites
- 2
- Number Of Participants
- 58
Sites
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Clinic of Eye Diseases
- Contact Person Name
- Vilma Jurate Balciuniene
- Contact Person Email
- jurate.balciuniene@kaunoklinikos.lt
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Centre of Eye Diseases
- Contact Person Name
- Andrius Cimbalas
- Contact Person Email
- andrius.cimbalas@santa.lt
Portugal
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 16-04-2026
- Processing Time Days
- 211
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Ophthalmology
- Contact Person Name
- Angela Carneiro
- Contact Person Email
- amvgcarneiro@gmail.com
- Site Name
- Association For Innovation And Biomedical Research On Light And Image
- Department Name
- Ophthalmology
- Contact Person Name
- Ines Marques
- Contact Person Email
- ipmarques@aibili.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Ophthalmology
- Contact Person Name
- Isabel Pires
- Contact Person Email
- isabel.maravilha@sapo.pt
Spain
- Earliest CTIS Part Ii Submission Date
- 11-09-2025
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 221
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Institut Catala De Retina S.L.
- Department Name
- Ophthalmology
- Contact Person Name
- Ignasi Jurgens Mestre
- Contact Person Email
- ignasi.jurgens@icrcat.com
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Ophthalmology
- Contact Person Name
- Javier Sambricio García
- Contact Person Email
- javiersambricio@gmail.com
- Site Name
- Miranza Galicia S.L.
- Department Name
- Ophthalmology
- Contact Person Name
- Maribel Fernandez Rodriguez
- Contact Person Email
- mariaisabel.fernandez@miranza.es
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Ophthalmology
- Contact Person Name
- Estanislao Gutierrez Sanchez
- Contact Person Email
- esgusan@hotmail.com
Sponsor
Primary sponsor
- Full Name
- 4d Molecular Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Syneos Health Netherlands B.V.
- Responsibilities
- Multiple trial operational responsibilities including transportation & payment coordination and other operational services (codes and specific duties listed in sponsor record).
- Name
- PPD International Holdings LLC
- Responsibilities
- Central lab for kit build, safety labs, and central repository for frozen samples.
- Name
- PPD Global Central Labs LLC
- Responsibilities
- Sample management and biorepository sample storage.
- Name
- Everest Clinical Research Corporation
- Responsibilities
- Operational/site support (responsibility codes listed; specific textual duty not provided).
- Name
- Suvoda LLC
- Responsibilities
- Operational support (responsibility code 3 listed; specific textual duty not provided).
- Name
- WCG Clinical Inc.
- Responsibilities
- Safety reporting to investigators and related pharmacovigilance support.
Third parties
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"eTMF build and hosting services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Kps Life LLC","duties_or_roles":"Monitoring Oversight vendor","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Drug labeling; kitting and distribution; drug depot, EU QP Release site","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Syneos Health Netherlands B.V.","duties_or_roles":"Transportation & Payment vendor; responsibilities codes: 1,12,13,15,2,5,8 (as listed)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Specialty Lab - Serology (immunogenicity) - ADA to 4D-R100 and aflibercept","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Optymedge LLC","duties_or_roles":"BCVA certification, Low Luminance visual acuity, manifest refraction, and lane certifications","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Central lab for kit build, safety labs, and central repository for frozen samples.","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"Safety database maintenance, regulatory intelligence, aggregate report writing, literature searches, master safety file maintenance, and case processing.","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Everest Clinical Research Corporation","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Safety reporting to investigators","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Duke University","duties_or_roles":"Central reading center for OCT, FA, CFP, anterior segment photography, Specular Microscopy images.","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"PPD Global Central Labs LLC","duties_or_roles":"Sample management and biorepository sample storage","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Eylea 40 mg/mL solution for injection in pre-filled syringe
- Active Substance
- Aflibercept
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVITREAL USE
- Route
- Intravitreal
- Authorisation Status
- Authorised (marketing authorisation present: EU/1/12/797/001 listed)
- Starting Dose
- 2 mg intravitreal
- Dose Levels
- 2 mg (intravitreal)
- Frequency
- Every 8 weeks (Q8W) for comparator arm
- Investigational Product Name
- 4D-150
- Active Substance
- Zunibergene rocparvovec (AAV containing VEGF-C and aflibercept transgene)
- Modality
- Gene therapy
- Routes Of Administration
- INTRAVITREAL USE
- Route
- Intravitreal
- Authorisation Status
- Investigational (no marketing authorisation listed)
- Starting Dose
- 3 ×10^10 vector genomes (vg) single intravitreal injection
- Dose Levels
- Single dose (3 ×10^10 vg) as specified in protocol
- Frequency
- Single intravitreal injection (single administration)
- Investigational Product Name
- DIFLUPREDNATE
- Active Substance
- Difluprednate
- Modality
- Small molecule
- Routes Of Administration
- TOPICAL USE (eye drops, emulsion)
- Route
- Topical (ocular)
- Authorisation Status
- Authorised (product record present)
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