Completed
DA VINCIA Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)
What is being tested
Laser Photocoagulation
+ Intravitreal Aflibercept Injection
ProcedureDrug
Who is being recruted
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: December 2008
Summary
Principal SponsorRegeneron Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2008
Actual date on which the first participant was enrolled.Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up
Official TitleA Double-Masked, Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap-Eye in Patients With Diabetic Macular Edema (DME)
Principal SponsorRegeneron Pharmaceuticals
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
221 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Patients with clinically significant DME with central involvement
Adults 18 years or older with type 1 or 2 diabetes mellitus with diabetic macular edema
ETDRS BCVA: 20/40 to 20/320 (letter score of 73 to 24) in the study eye
7 exclusion criteria prevent from participating
History of vitreoretinal surgery in the study eye
Panretinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of screening
Previous use of intraocular or periocular corticosteroids in the study eye within 3 months of screening
Previous treatment with anti-angiogenic drugs in either eye (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) within 3 months of screening
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
5 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorFocal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.
Group II
ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
Group III
ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
Group IV
ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
Group 5
ExperimentalIntravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers