Trial Condition(s):

Retinal disease

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 (MAIA)

Bayer Identifier:

19212

ClinicalTrials.gov Identifier:

NCT04137120

EudraCT Number:

Not Available

Recruitment Complete

Trial Purpose

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 blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.

Inclusion Criteria
- 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 Criteria
- 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

Trial Summary

Enrollment Goal
73
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Mexico

Status
Recruiting
 

Trial Design