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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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 afliberceptExclusion 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 studyTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many locations Many locations, Mexico | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
Assessment of the safety and drug utilization of intravitreal aflibercept injection in Mexican routine clinical practice for the treatment of wet age related macular degeneration (wAMD), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) and myopic neovascularization (mCNV). A post-authorization safety study (PASS).
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of ocular adverse eventsTimeframe: Up to 12 months
- Number of serious ocular adverse eventsTimeframe: Up to 12 months
- Seriousness reason for ocular adverse eventsSeriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.Timeframe: Up to 12 months
- Severity of ocular adverse eventsThe severity of adverse events is classified as mild, moderate or severe by treating physician.Timeframe: Up to 12 months
- Number of treatment-related ocular adverse eventsTimeframe: Up to 12 months
- Number of injection-related ocular adverse eventsTimeframe: Up to 12 months
- Action taken with drug after ocular adverse eventOptions: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changedTimeframe: Up to 12 months
- Clinical outcome of ocular adverse eventOptions: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, UnknownTimeframe: Up to 12 months
- Duration of ocular adverse eventsTimeframe: Up to 12 months
- Duration of patient follow-up after ocular adverse event (in months)Timeframe: Up to 12 months
- Number of non-ocular adverse eventsTimeframe: Up to 12 months
- Number of serious non-ocular adverse eventsTimeframe: Up to 12 months
- Seriousness reason for non-ocular adverse eventsSeriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.Timeframe: Up to 12 months
- Severity of non-ocular adverse eventsThe severity of adverse events is classified as mild, moderate or severe by treating physician.Timeframe: Up to 12 months
- Number of treatment-related non-ocular adverse eventsTimeframe: Up to 12 months
- Number of injection-related non-ocular adverse eventsTimeframe: Up to 12 months
- Action taken with drug after non-ocular adverse eventOptions: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changedTimeframe: Up to 12 months
- Clinical outcome of non-ocular adverse eventOptions: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, UnknownTimeframe: Up to 12 months
- Duration of non-ocular adverse eventsTimeframe: Up to 12 months
- Duration of patient follow-up after non-ocular adverse event (in months)Timeframe: Up to 12 months
Secondary Outcome
- Total number of injections with intravitreal aflibercept per study eyeTimeframe: Up to 12 months
- Time between injections in the study eye (in days)Timeframe: Up to 12 months
- Time between injections in the study eye and fellow eye (in days)Timeframe: Up to 12 months
- Number of patients receiving bilateral treatmentTimeframe: Up to 18 months
Additional Information
Not Available
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