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CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
EU CTIS ID: 2025-523938-10-00
What this study is testing
To evaluate the efficacy of EYP-1901 2686 μg intravitreal (IVT) inserts on best corrected visual acuity (BCVA) changes compared to aflibercept treatment.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied: 1. Male or female participants, ≥18 years of age.
- 2. Participants with a diagnosis of diabetes mellitus (DM; Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association. Must have stable DM for a minimum of 3 months prior to the Screening Visit, currently managed with use of oral antihyperglycemic agents, insulin, or other injectable drugs.
- 3. Hemoglobin A1c (HbA1c) <10% at the Screening Visit.
- 4. Able to understand, and willingness to sign, the informed consent. For US participants only: must be willing to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
- 5. Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
- 6. For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.
You likely can't join if
- Participants who meet any of the following exclusion criteria will be excluded from the study. 1. Ocular Exclusion Criteria for the Study Eye Only 2. Ocular Exclusion Criteria for Either Eye 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2.
See the full eligibility criteria
- Participants will be considered eligible for participation in the study if all of the following inclusion criteria are satisfied: 1. Male or female participants, ≥18 years of age.
- 2. Participants with a diagnosis of diabetes mellitus (DM; Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association. Must have stable DM for a minimum of 3 months prior to the Screening Visit, currently managed with use of oral antihyperglycemic agents, insulin, or other injectable drugs.
- 3. Hemoglobin A1c (HbA1c) <10% at the Screening Visit.
- 4. Able to understand, and willingness to sign, the informed consent. For US participants only: must be willing to provide access to personal health information via Health Insurance Portability and Accountability Act (HIPAA) authorization.
- 5. Willingness and ability to comply with all scheduled visits, restrictions, and assessments.
- 6. For women of childbearing potential, or men with female partners of childbearing potential, agreement to the use of an appropriate form of contraception at the Screening Visit and for the duration of the study.
- Ocular Inclusion Criteria for Study Eye: 7. Previously diagnosed with macular edema associated with diabetic retinopathy (DR) at any time For the full list of the inclusion criteria please refer to Protocol section 4.1.
- Participants who meet any of the following exclusion criteria will be excluded from the study. 1. Ocular Exclusion Criteria for the Study Eye Only 2. Ocular Exclusion Criteria for Either Eye 3. General Exclusion Criteria For the full list of the exclusion criteria please refer to Protocol section 4.2.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.