NCT05511038

A Study to Learn How Safe the Study Drug Intravitreal (Given by an Injection Into the Eye) Aflibercept is in Participants in India With Diabetic Macular Edema

A Phase IV Interventional Post Approval Trial to Assess the Safety of Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema (DME) in Patients in India.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for a better way to treat people who have diabetic macular edema (DME). Diabetic macular edema (DME) is a complication of diabetes. Consistently high blood sugar due to poor glucose control over time can damage small blood vessels in the body, including the eye. Damaged blood vessels in the eye may lead to leakage of the fluid into the central part of the retina at the back of the eye (also called macula) where sharp, straight-ahead vision occurs. Fluid accumulation makes the macula swell and results in reduced vision. If not treated, DME can result in complete loss of central detailed vision. The study treatment intravitreal aflibercept (also called BAY865321) works by blocking VEGFR-1 receptor activity. Intravitreal aflibercept is already approved in over 105 countries for doctors to prescribe to people with DME. In India, aflibercept is approved conditionally for people with DME. The reason for this is that the sponsor was asked to collect more safety data for intravitreal aflibercept in Indian people with DME. The main purpose of this study is to collect more data to learn how safe intravitreal aflibercept is in Indian people with DME. To see how safe intravitreal aflibercept is, the researchers will collect the information/data on the medical problems the participants may have during the study, and which may or may not be related to the study treatment. These medical problems are also known as "adverse events" (AEs). AEs will be categorized according to relatedness, seriousness, discontinuation of therapy, action taken and outcome. The study participants will receive aflibercept as an injection directly into the space in the back of the eye once every 4 weeks in the first 5 months, followed by one injection every 8 weeks for the rest of the study duration. Only one eye per participant to be treated with aflibercept will be considered for the study. Each participant will be in the study for approximately 52 weeks. The treatment duration will be 48 weeks. For each participant 11 visits to the study site are planned. The study team will perform additional safety calls 16 to 36 hours after each visit starting at visit 2. Alternatively, an additional safety visit can be arranged/planned for the day after treatment. During the study, the study team will: * take blood and urine samples * examine the participants' eyes * do physical examinations * examine heart health using ECG * check vital signs * ask the participants questions about how they are feeling and what adverse events they are having. * in- administer the study drug At the end of the study the participants will be switched to commercially available treatment if recommended by the study doctor/if the participant still benefits from the treatment.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)	Injection, 2mg (equivalent to 50 µL solution for injection)

Timeline

• Start date: 2022-08-26
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2022-08-22
• Last updated: 2025-09-04
• Results posted: 2025-09-04

Locations

10 sites across 1 country: India

Regulatory

• FDA-regulated drug study