Status:
COMPLETED
Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical Practice
Lead Sponsor:
Bayer
Conditions:
Retinal Disease
Eligibility:
All Genders
18+ years
Brief Summary
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or...
Detailed Description
The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic ...
Eligibility Criteria
Inclusion
- Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV);
- Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
- Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
- If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Exclusion
- Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
- Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
- Current treatment with other intravitreal therapies
- Contra-indications according to Eylea's / Wetlia's local marketing authorization:
- Ocular or periocular infection
- Active intraocular Inflammation
- Known hypersensitivity to aflibercept or to any of its excipients
- Pregnant or lactating women.
- Participation in an interventional study
Key Trial Info
Start Date :
February 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04137120
Start Date
February 19 2021
End Date
February 1 2023
Last Update
February 17 2023
Active Locations (1)
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1
Many locations
Multiple Locations, Mexico