Clinical trial • Phase III • Ophthalmology
CENEGERMIN for Persistent corneal epithelial defect
Phase III trial of CENEGERMIN for Persistent corneal epithelial defect.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Persistent corneal epithelial defect
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 08-01-2026
- First CTIS Authorization Date
- 05-05-2026
Trial design
Randomised, oxervate 20 micrograms/ml eye drops, solution (active product; dose: 20 micrograms/ml) and vehicle for cenegermin drug product (placebo/control). dose schedule not specified in the ctis record. Phase III trial in Czechia, France, Germany and others.
- Randomised
- Yes
- Comparator
- OXERVATE 20 micrograms/ml eye drops, solution (active product; dose: 20 micrograms/ml) and Vehicle for cenegermin drug product (placebo/control). Dose schedule not specified in the CTIS record.
- Target Sample Size
- 124
Eligibility
Recruits 124 No vulnerable populations selected. Participants must be able to sign the informed consent as described in the protocol (ICF). No provisions for assent of minors are provided because the study enrols adults (≥18 years)..
- Pregnancy Exclusion
- Contraception: a. Females of child-bearing age (defined as not surgically sterilized or post-menopausal for at least 1 year) are excluded if they meet any 1 of the following conditions: − Are known to be pregnant − Have a positive urine pregnancy test at baseline visit − Are planning to become pregnant during study period − Are breastfeeding − Are unwilling to use acceptable form of contraception until 30 days after the study treatment period is complete b. Male fertile participants (ie, not surgically sterilized by vasectomy) unwilling to use an acceptable form of contraception (male condom with spermicidal cream or jelly) until 30 days after the study treatment period is complete
- Vulnerable Population
- No vulnerable populations selected. Participants must be able to sign the informed consent as described in the protocol (ICF). No provisions for assent of minors are provided because the study enrols adults (≥18 years).
Inclusion criteria
- {"criterion_text":"- Men or women aged 18 years or above"}
- {"criterion_text":"- Participants with PCED in the study eye with the following characteristics: a. PCED ≥ 1.0 mm in greatest diameter b. PCED of at least 14 days duration, refractory to 1 or more conventional nonsurgical treatments (ocular lubricants, discontinuation of preserved drops and medications, bandage contact lens) showing no clinical resolution."}
- {"criterion_text":"- Use of most ophthalmic medications (including glaucoma medications) indicated for ocular conditions other than PCED is permitted in the study eye, if the participant has been on a stable dose for at least 30 days and does not expect to have change in dosing regimen throughout the entire duration of the study. Please see exclusion criteria list for exceptions."}
- {"criterion_text":"- Use of prophylactic antibiotics in the study eye is permitted if the participant is already receiving them prior to enrollment."}
- {"criterion_text":"- Able to sign the inform consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF)."}
Exclusion criteria
- {"criterion_text":"- Contralateral eye with vision of no light perception or anatomic absence of contralateral eye."}
- {"criterion_text":"- Known active substance abuse or dependency, including but not limited to alcohol, illicit drugs, marijuana, or misuse of prescription medications within 30 days of randomization"}
- {"criterion_text":"- Known or suspected ocular malignancy (e.g., ocular surface, intraocular, ocular adnexa), or presence of cancer or any other systemic disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma of the head"}
- {"criterion_text":"- Any ocular or systemic disorder that might hinder the efficacy of the study treatment or its evaluation or could be judged by the investigator to be incompatible with the study visit schedule or conduct"}
- {"criterion_text":"- Concurrent participation in another investigational study"}
- {"criterion_text":"- Hypersensitivity: a. Known or suspected allergy to any components of the cenegermin formulation b. Known hypersensitivity to 1 of the components of the study or procedural medications (eg, fluorescein)"}
- {"criterion_text":"- Active ocular infection or inflammation in the study eye as follows: a. Bacterial, fungal, or protozoal infection at screening b. Active infectious stromal infiltrates or edema at screening c. Acute anterior uveitis of grade 2 or greater (SUN 2025) within 30 days of screening d. Acute intermediate uveitis or posterior uveitis within 30 days of screening e. Acute inflammation of the sclera or conjunctiva if it is not associated with the PCED"}
- {"criterion_text":"- Corneal epithelial defect associated with stromal thinning greater than 30% (estimated on clinical slit lamp exam) or if associated with stromal infiltrate (corneal haze is acceptable), in the study eye."}
- {"criterion_text":"- Severe eyelid disease in the study eye, such as: a. Mechanical eyelid abnormalities that have direct contact with the PCED (e.g., trichiasis, severe entropion with lid margin keratinization, etc, if in direct contact with the PCED) b. Lagophthalmos greater than 2 mm as measured in the clinic c. Existing diagnosis of nocturnal lagophthalmos or Parkinson’s disease d. Inability to fully close eyelids despite voluntary eyelid closure e. Severe ectropion with abnormal eyelid-globe congruity (e.g., the lower eyelid does not come into contact with the globe due to severe ectropion)"}
- {"criterion_text":"- Severe end-stage ocular surface disease in the study eye, including but not limited to: a. Severe limbal stem cell deficiency, defined as involvement of more than 270 cumulative degrees or more of limbal stem cell deficiency b. Keratinization of the bulbar conjunctiva or lid margin"}
- {"criterion_text":"- Use of the following medications and devices within the indicated time window prior to randomization: a. Local medications in study eye: − Any prior use of cenegermin − Blood-derived (autologous serum) or other ocular surface re-epithelizing agents, anesthetic use by the participant outside of the clinical exam setting, insulin, or steroids (unless associated with post-operative treatment regimen) within 7 days − Botox (botulinum toxin) injections for pharmacologic tarsorrhaphy within 90 days b. Systemic medications: − High-dose systemic corticosteroids (greater than 0.5 mg/kg/day) within 30 days − Any changes in oral medication regimen intended for the treatment of the ocular surface (eg, oral doxycycline) within 30 days, or planned changes during the study period − Systemic opioid use within 30 days − Use of any systemic investigational product, ocular investigational product in the study eye, radiation of the head or neck, or systemic chemotherapy within 90 days, or planned to occur during the study period c. Devices: − Use of contact lens (including therapeutic contact lens) within 7 days, or planned use of contact lens during the study period, in the study eye − Anticipated need for punctal occlusion in the study eye during the study period. Participants with punctal occlusion or punctal plugs inserted prior to the study are eligible for enrolment provided that the punctual occlusion is maintained throughout the study."}
- {"criterion_text":"- Presence of acute severe systemic disease as follows: a. Any acute or active severe systemic inflammatory disease (eg, acute systemic Stevens-Johnson Syndrome, acute systemic GVHD, severe systemic Sjogren’s, mucous membrane pemphigoid) b. Presence of any systemic disease that may affect ability to participate in the clinical study according to the clinical judgment of the investigator"}
- {"criterion_text":"- Recent surgery or amniotic membrane therapy as follows: a. Recent major surgical procedure for the treatment of PCED (eg, conjunctival flap, complete tarsorrhaphy, superficial keratectomy for epithelial defect revision, etc) within 14 days of randomization b. Presence of amniotic membrane from AMT for ocular surface indication if not dissolved within area of PCED within 14 days of randomization. Examples include: − Sutured AMT − Self-retaining AMT −Contact lens combined with AMT −Other AMT treatment for the ocular surface c. Partial tarsorrhaphy (temporary or permanent) placed within 14 days of randomization. If a participant is enrolled with partial tarsorrhaphy placed more than 14 days prior to randomization, then the tarsorrhaphy must not be removed for the entire duration of the study."}
- {"criterion_text":"- Contraception: a. Females of child-bearing age (defined as not surgically sterilized or post-menopausal for at least 1 year) are excluded if they meet any 1 of the following conditions: − Are known to be pregnant − Have a positive urine pregnancy test at baseline visit − Are planning to become pregnant during study period − Are breastfeeding − Are unwilling to use acceptable form of contraception until 30 days after the study treatment period is complete b. Male fertile participants (ie, not surgically sterilized by vasectomy) unwilling to use an acceptable form of contraception (male condom with spermicidal cream or jelly) until 30 days after the study treatment period is complete"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Achieving complete epithelial healing at week 4 and maintained at week 8.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Percentage change from baseline in maximum diameter of PCED at week 4","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percentage change from baseline in maximum diameter of PCED at week 8","definition_or_measurement_approach":""}
- {"endpoint_text":"- Achieving complete epithelial healing at week 8 and maintained at week 10","definition_or_measurement_approach":""}
- {"endpoint_text":"- Linear change from baseline in maximum diameter (in mm) of the PCED at week 4","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 124
- Recruitment Window Months
- 28
- Consent Approach
- Informed consent must be signed by the participant (able to sign the informed consent as described in the protocol). Study enrols adults (≥18 years). Country-specific ICFs and related documents are provided (examples in Czech, French, German, Hungarian, Italian, Spanish, Dutch, Polish and English). Pregnant-participant and pregnant-partner forms are available where applicable. No assent of minors (study population excludes <18).
Geography
- Total Number Of Sites
- 38
- Total Number Of Participants
- 91
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-04-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- 552: Ocni klinika
- Principal Investigator Name
- Pavlina Skalicka
- Principal Investigator Email
- pavlina.skalicka@vfn.cz
- Contact Person Name
- Pavlina Skalicka
- Contact Person Email
- pavlina.skalicka@vfn.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- 551: Ocni klinika
- Principal Investigator Name
- Dominika Ivanisova
- Principal Investigator Email
- ivanisova.dominika@fnbrno.cz
- Contact Person Name
- Dominika Ivanisova
- Contact Person Email
- ivanisova.dominika@fnbrno.cz
France
- Earliest CTIS Part Ii Submission Date
- 24-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Universitaire De Saint Etienne
- Department Name
- 302; Département d’Ophtalmologie
- Principal Investigator Name
- Philippe Gain
- Principal Investigator Email
- philippe.gain@univ-st-etienne.fr
- Contact Person Name
- Philippe Gain
- Contact Person Email
- philippe.gain@univ-st-etienne.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- 306; Service d’Ophtalmologie
- Principal Investigator Name
- Béatrice Cochener
- Principal Investigator Email
- beatrice.cochener@ophtalmologie-chu29.fr
- Contact Person Name
- Béatrice Cochener
- Contact Person Email
- beatrice.cochener@ophtalmologie-chu29.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- 305; Service d’Ophtalmologie
- Principal Investigator Name
- Pierre-Jean Pisella
- Principal Investigator Email
- PJ.PISELLA@chu-tours.fr
- Contact Person Name
- Pierre-Jean Pisella
- Contact Person Email
- PJ.PISELLA@chu-tours.fr
- Site Name
- Fondation A De Rothschild
- Department Name
- 304; Service d’Ophtalmologie
- Principal Investigator Name
- Eric Gabison
- Principal Investigator Email
- egabison@for.paris
- Contact Person Name
- Eric Gabison
- Contact Person Email
- egabison@for.paris
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- 303; OphtalmoPôle
- Principal Investigator Name
- Jean-Louie Bourges
- Principal Investigator Email
- Jean-louis.bourges@aphp.fr
- Contact Person Name
- Jean-Louie Bourges
- Contact Person Email
- Jean-louis.bourges@aphp.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 07-04-2026
- Latest Decision Or Authorization Date
- 06-05-2026
- Processing Time Days
- 29
- Number Of Sites
- 8
- Number Of Participants
- 11
Sites
- Site Name
- Universitaet Des Saarlandes
- Department Name
- 402: Klinik für Augenheilkunde
- Principal Investigator Name
- Berthold Seitz
- Principal Investigator Email
- berthold.seitz@uks.eu
- Contact Person Name
- Berthold Seitz
- Contact Person Email
- berthold.seitz@uks.eu
- Site Name
- Kliniken der Stadt Koeln gGmbH
- Department Name
- 407: Augenklinik
- Principal Investigator Name
- Norbert Schrage
- Principal Investigator Email
- schrageN@kliniken-koeln.de
- Contact Person Name
- Norbert Schrage
- Contact Person Email
- schrageN@kliniken-koeln.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- 406: Augenklinik
- Principal Investigator Name
- Theofilos Tourtas
- Principal Investigator Email
- Theofilos.Tourtas@uk-erlangen.de
- Contact Person Name
- Theofilos Tourtas
- Contact Person Email
- Theofilos.Tourtas@uk-erlangen.de
- Site Name
- Goethe University Frankfurt
- Department Name
- 403: Klinik für Augenheilkunde
- Principal Investigator Name
- Thomas Kohnen
- Principal Investigator Email
- Thomas.kohnen@unimedizin-ffm.de
- Contact Person Name
- Thomas Kohnen
- Contact Person Email
- Thomas.kohnen@unimedizin-ffm.de
- Site Name
- Philipps-Universitaet Marburg
- Department Name
- 405: Klinik für Augenheilkunde
- Principal Investigator Name
- Walter Sekundo
- Principal Investigator Email
- sekundo@staff.uni-marburg.de
- Contact Person Name
- Walter Sekundo
- Contact Person Email
- sekundo@staff.uni-marburg.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- 401: Klinik für Augenheilkunde
- Principal Investigator Name
- Gerd Geerling
- Principal Investigator Email
- geerling@med.uni-duesseldorf.de
- Contact Person Name
- Gerd Geerling
- Contact Person Email
- geerling@med.uni-duesseldorf.de
- Site Name
- Universitaetsklinikum Koeln AöR
- Department Name
- 404: Zentrum für Augenheilkunde
- Principal Investigator Name
- Claus Cursiefen
- Principal Investigator Email
- claus.cursiefen@uk-koeln.de
- Contact Person Name
- Claus Cursiefen
- Contact Person Email
- claus.cursiefen@uk-koeln.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- 408: Klinik für Augenheilkunde
- Principal Investigator Name
- Eckart Bertelmann
- Principal Investigator Email
- Eckart.bertelmann@charite.de
- Contact Person Name
- Eckart Bertelmann
- Contact Person Email
- Eckart.bertelmann@charite.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 21-04-2026
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 20
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Semmelweis University
- Department Name
- 652 :Szemészeti Klinika
- Principal Investigator Name
- Zoltán Nagy
- Principal Investigator Email
- nagy.zoltan.zsolt@semmelweis.hu
- Contact Person Name
- Zoltán Nagy
- Contact Person Email
- nagy.zoltan.zsolt@semmelweis.hu
- Site Name
- Vididit Kft.
- Department Name
- 651: NAP
- Principal Investigator Name
- Ákos Vadnay
- Principal Investigator Email
- vadnayszemeszet@gmail.com
- Contact Person Name
- Ákos Vadnay
- Contact Person Email
- vadnayszemeszet@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 21-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 17
- Number Of Sites
- 7
- Number Of Participants
- 17
Sites
- Site Name
- Hospital Santa Maria Della Misericordia
- Department Name
- 102; Oculistica
- Principal Investigator Name
- Carlo Cagini
- Principal Investigator Email
- carlo.cagini@unipg.it
- Contact Person Name
- Carlo Cagini
- Contact Person Email
- carlo.cagini@unipg.it
- Site Name
- ASST Fatebenefratelli Sacco
- Department Name
- 101; SC Oculistica
- Principal Investigator Name
- Stefano Barabino
- Principal Investigator Email
- stebarabi@gmail.com
- Contact Person Name
- Stefano Barabino
- Contact Person Email
- stebarabi@gmail.com
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- 107; Unità di Oculistica
- Principal Investigator Name
- Francesco Bandello
- Principal Investigator Email
- bandello.francesco@hsr.it
- Contact Person Name
- Francesco Bandello
- Contact Person Email
- bandello.francesco@hsr.it
- Site Name
- Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia
- Department Name
- 103; UOS Cornea, cristallino e oftalmoplastica
- Principal Investigator Name
- Domenico Schiano Lomoriello
- Principal Investigator Email
- domenico.schiano@fondazionebietti.it
- Contact Person Name
- Domenico Schiano Lomoriello
- Contact Person Email
- domenico.schiano@fondazionebietti.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- 105; Oculistica
- Principal Investigator Name
- Giovanni Milano
- Principal Investigator Email
- gmilano@unipv.it
- Contact Person Name
- Giovanni Milano
- Contact Person Email
- gmilano@unipv.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- 106: Oculistica
- Principal Investigator Name
- Rita Mencucci
- Principal Investigator Email
- rita.mencucci@unifi.it
- Contact Person Name
- Rita Mencucci
- Contact Person Email
- rita.mencucci@unifi.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- 107; Unità di Oculistica
Spain
- Earliest CTIS Part Ii Submission Date
- 24-04-2026
- Latest Decision Or Authorization Date
- 07-05-2026
- Processing Time Days
- 13
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- 202: Oftalmología
- Principal Investigator Name
- Antoni Sabala Llopart
- Principal Investigator Email
- asabala.germanstrias@gencat.cat
- Contact Person Name
- Antoni Sabala Llopart
- Contact Person Email
- asabala.germanstrias@gencat.cat
- Site Name
- Fundacion De Oftalmologia Medica De La Comunitat Valenciana
- Department Name
- 205: Oftalmología
- Principal Investigator Name
- Marta Cerda Ibañez
- Principal Investigator Email
- marta.cerda@fom.es
- Contact Person Name
- Marta Cerda Ibañez
- Contact Person Email
- marta.cerda@fom.es
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- 203: Oftalmología
- Principal Investigator Name
- Carlos Rocha de Lossada
- Principal Investigator Email
- carlosrochadelossada5@gmail.com
- Contact Person Name
- Carlos Rocha de Lossada
- Contact Person Email
- carlosrochadelossada5@gmail.com
- Site Name
- Instituto Universitario De Oftalmobiologia Aplicada
- Department Name
- 206: Oftalmología
- Principal Investigator Name
- Margarita Calonge
- Principal Investigator Email
- calonge@ioba.med.uva.es
- Contact Person Name
- Margarita Calonge
- Contact Person Email
- calonge@ioba.med.uva.es
- Site Name
- Instituto De Microcirugia Ocular Dos S.L.
- Department Name
- 204: Oftalmología
- Principal Investigator Name
- Jose Luis Güell Villanueva
- Principal Investigator Email
- jose.guell@imo.es
- Contact Person Name
- Jose Luis Güell Villanueva
- Contact Person Email
- jose.guell@imo.es
- Site Name
- Clinica De Oftalmologia De Cordoba S.L.
- Department Name
- 201: Oftalmología
- Principal Investigator Name
- Alberto Villarrubia Cuadrado
- Principal Investigator Email
- alvillarrubia@yahoo.com
- Contact Person Name
- Alberto Villarrubia Cuadrado
- Contact Person Email
- alvillarrubia@yahoo.com
- Site Name
- Centro De Ojos De La Coruna S.L.
- Department Name
- 207: Oftalmología
- Principal Investigator Name
- Carlos Mendez Mangana
- Principal Investigator Email
- cmendezmangana@gmail.com
- Contact Person Name
- Carlos Mendez Mangana
- Contact Person Email
- cmendezmangana@gmail.com
- Site Name
- Hospital Universitario Regional De Malaga (duplicate entry?)
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-04-2026
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 13
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- The Rotterdam Eye Hospital
- Department Name
- 502: Ophthalmology
- Principal Investigator Name
- Anna Randag
- Principal Investigator Email
- a.randag@oogziekenhuis.nl
- Contact Person Name
- Anna Randag
- Contact Person Email
- a.randag@oogziekenhuis.nl
- Site Name
- Amsterdam UMC Stichting
- Department Name
- 501: Ophthalmology
- Principal Investigator Name
- Ruth Lapid-Gortzak
- Principal Investigator Email
- r.lapid@amsterdamumc.nl
- Contact Person Name
- Ruth Lapid-Gortzak
- Contact Person Email
- r.lapid@amsterdamumc.nl
- Site Name
- Universitair Medisch Centrum Utrecht
- Department Name
- 503: Ophthalmology
- Principal Investigator Name
- Mor Dickman
- Principal Investigator Email
- m.m.dickman@umcutrecht.nl
- Contact Person Name
- Mor Dickman
- Contact Person Email
- m.m.dickman@umcutrecht.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 21-04-2026
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 17
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Gabinet Okulistyczny Prof Edward Wylegala
- Department Name
- 601:Ophtalmology
- Principal Investigator Name
- Adam Wylegala
- Principal Investigator Email
- adam.wylegala@gmail.com
- Contact Person Name
- Adam Wylegala
- Contact Person Email
- adam.wylegala@gmail.com
- Site Name
- Samodzielny Publiczny Kliniczny Szpital Okulistyczny W Warszawie
- Department Name
- 602:Ophtalmology
- Principal Investigator Name
- Jacek Szaflik
- Principal Investigator Email
- jacek.szaflik@wum.edu.pl
- Contact Person Name
- Jacek Szaflik
- Contact Person Email
- jacek.szaflik@wum.edu.pl
- Site Name
- Gabinety Okulistyczne Sp. z o.o.
- Department Name
- 603:Opthalmology
- Principal Investigator Name
- Agnieszka Cwiklinska-Haszcz
- Principal Investigator Email
- acwiklinskahaszcz@ocho.pl
- Contact Person Name
- Agnieszka Cwiklinska-Haszcz
- Contact Person Email
- acwiklinskahaszcz@ocho.pl
Sponsor
Primary sponsor
- Full Name
- Dompe' Farmaceutici S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Contract research organisations
- Name
- Parexel International (IRL) Limited
- Responsibilities
- sponsorDuties codes: 1,10,11,12,13,14,5,6,8
- Name
- Merit CRO Inc.
- Responsibilities
- reading centre, rater training
- Name
- CluePoints
- Responsibilities
- Central data monitoring platform
- Name
- BAP Pharma GmbH
- Responsibilities
- sponsorDuties code: 14
- Name
- Medidata Solutions Inc.
- Responsibilities
- sponsorDuties codes: 3,7
Third parties
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,14,5,6,8","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"CluePoints","duties_or_roles":"Central data monitoring platform","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"reading centre, rater training","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"BAP Pharma GmbH","duties_or_roles":"sponsorDuties code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 3,7","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- OXERVATE 20 micrograms/ml eye drops, solution
- Active Substance
- CENEGERMIN
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- OCULAR USE
- Route
- ocular
- Authorisation Status
- Marketing authorisation EU/1/17/1197/001 (prodAuthStatus 2)
- Starting Dose
- 20 micrograms/ml
- Investigational Product Name
- Vehicle for cenegermin drug product
- Modality
- Other
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