AFLIBERCEPT for Diabetic Macular Edema

Inclusion criteria

• {"criterion_text":"- Participant reads, understands, and signs an independent ethics committee (IEC)/institutional review board (IRB) approved informed consent form (ICF) prior to any study-specific procedure. If the participant is unable to read and/or write, an impartial witness should be present during the entire informed consent discussion.\n- Participant is ≥18 years old at the time of signing the ICF.\n- Participant has a diagnosis of type 1 or 2 diabetes mellitus (DM) with glycated hemoglobin (HbA1c) <12% at screening. For the full list of inclusion criteria please refer to protocol"}

Exclusion criteria

• {"criterion_text":"- Participant has one or more of the following current ocular conditions in the study eye: a.\tProliferative diabetic retinopathy. b.\tPre-retinal fibrosis involving the macula. c.\tAphakia or absence of the posterior capsule. For the full list of ocular conditions please refer to protocol.\n- Participant has a history of one or more of the following ocular conditions in the study eye: a.\tAny intraocular inflammation/infection within 90 days prior to screening. b.\tNon-infectious uveitis, or idiopathic or autoimmune uveitis. For the full list of ocular conditions please refer to protocol.\n- Participant has a hypersensitivity to immunoglobulin products, or has allergies to any of the components of the study treatments\n- Participant currently suffering from or having a history of (where indicated) one or more of the following systemic conditions: a.\tUncontrolled blood pressure b.\tHistory of vascular disease such as cerebrovascular accident, myocardial infarction, transient ischemic attack, or thromboembolic reaction including pulmonary embolism within 180 days prior to baseline c.\tNew York Heart Association Functional Classification Class III or IV heart failure, or severe uncontrolled cardiac disease (ie, unstable angina). For the full list of exclusion criteria please refer to protocol"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in best-corrected visual acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score","definition_or_measurement_approach":"BCVA measured by ETDRS letter score; endpoint is change from baseline in BCVA as measured by the ETDRS letter score."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in BCVA as assessed by ETDRS letter score throughout the study at several pre-defined time points","definition_or_measurement_approach":"BCVA measured by ETDRS letter score at multiple pre-defined time points; change from baseline."}
• {"endpoint_text":"- Gain of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points","definition_or_measurement_approach":"Proportion of participants achieving gains of ≥5, ≥10, and ≥15 ETDRS letters from baseline at pre-defined time points."}
• {"endpoint_text":"- Loss of ≥5, ≥10, and ≥15 letter score in BCVA by ETDRS from baseline throughout the study at several pre-defined time points","definition_or_measurement_approach":"Proportion of participants with losses of ≥5, ≥10, and ≥15 ETDRS letters from baseline at pre-defined time points."}
• {"endpoint_text":"- Change from baseline in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT) throughout the study at several pre-defined time points","definition_or_measurement_approach":"CST measured by SD-OCT; change from baseline at multiple pre-defined time points."}
• {"endpoint_text":"- Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points","definition_or_measurement_approach":"Absence/presence of IRF assessed by SD-OCT at pre-defined time points compared with baseline."}
• {"endpoint_text":"- Absence of intraretinal fluid (IRF) as assessed by SD-OCT from baseline throughout the study at several pre-defined time points during the trial","definition_or_measurement_approach":"Absence/presence of IRF assessed by SD-OCT at pre-defined time points during the trial compared with baseline."}
• {"endpoint_text":"- Incidence of ocular and non-ocular treatment-emergent adverse events, adverse events of special interest, and serious adverse events","definition_or_measurement_approach":"Collection and tabulation of treatment-emergent adverse events (ocular and non-ocular), AEs of special interest, and SAEs per standard safety reporting procedures."}
• {"endpoint_text":"- Evaluation of ophthalmic parameters (intraocular pressure [IOP], biomicroscopy, and indirect ophthalmoscopy)","definition_or_measurement_approach":"Assessment of IOP, biomicroscopy and indirect ophthalmoscopy findings at scheduled visits."}
• {"endpoint_text":"- Evaluation of routine safety parameters","definition_or_measurement_approach":"Routine laboratory and safety parameter assessments per protocol schedule."}
• {"endpoint_text":"- Incidence and titer of anti-drug antibodies at several pre-defined time points during the study","definition_or_measurement_approach":"Measurement of anti-drug antibody incidence and titers at pre-defined time points."}
• {"endpoint_text":"- Incidence of neutralizing antibodies at several pre-defined time points during the study","definition_or_measurement_approach":"Assessment of neutralizing antibody incidence at scheduled time points."}
• {"endpoint_text":"- Evaluation of the systemic PK of free and bound aflibercept at several pre-defined time points during the study","definition_or_measurement_approach":"Systemic pharmacokinetic sampling and analysis for free and bound aflibercept at pre-defined time points."}

Bulgaria

Earliest CTIS Part Ii Submission Date

22-01-2026

Latest Decision Or Authorization Date

11-03-2026

Processing Time Days

48

Number Of Sites

5

Number Of Participants

27

Czechia

Earliest CTIS Part Ii Submission Date

06-02-2026

Latest Decision Or Authorization Date

09-03-2026

Processing Time Days

31

Number Of Sites

5

Number Of Participants

27

Hungary

Earliest CTIS Part Ii Submission Date

19-01-2026

Latest Decision Or Authorization Date

12-03-2026

Processing Time Days

52

Number Of Sites

7

Number Of Participants

32

Latvia

Earliest CTIS Part Ii Submission Date

13-11-2025

Latest Decision Or Authorization Date

06-03-2026

Processing Time Days

113

Number Of Sites

2

Number Of Participants

11

Poland

Earliest CTIS Part Ii Submission Date

10-02-2026

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

31

Number Of Sites

9

Number Of Participants

38

Slovakia

Earliest CTIS Part Ii Submission Date

05-03-2026

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

12

Number Of Sites

7

Number Of Participants

37

Primary sponsor

Full Name

Alvotech Swiss AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

codes 1,10,11,12,13,2,3,5,6

Name

Norwich Clinical Services Private Limited

Responsibilities

code 8

Name

Eresearchtechnology Inc.

Responsibilities

Cardiac Safety

Third parties

• {"country":"United Kingdom","full_name":"Eyeknow Clinical Ltd.","duties_or_roles":"BCVA certification","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Cardiac Safety","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"codes 1,10,11,12,13,2,3,5,6","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Nuvisan GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"Portugal","full_name":"Association For Innovation And Biomedical Research On Light And Image","duties_or_roles":"Ophtalmology reading centre","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"India","full_name":"Norwich Clinical Services Private Limited","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code 7","organisation_type":"Non-Pharmaceutical company"}