Clinical trial NCT04137120: 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
Official title: 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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Disease
Keywords: Aflibercept
Intravitreal injection
Ocular disease
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)
Myopic choroidal neovascularization (mCNV)
Mexico
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with macular disease in Mexican routine practice

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

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 macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO).

Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.

Eligibility criteria: 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

Primary outcomes:
measure: Number of ocular adverse events
timeFrame: Up to 12 months
measure: Number of serious ocular adverse events
timeFrame: Up to 12 months
measure: Seriousness reason for ocular adverse events
timeFrame: Up to 12 months
measure: Severity of ocular adverse events
timeFrame: Up to 12 months
measure: Number of treatment-related ocular adverse events
timeFrame: Up to 12 months
measure: Number of injection-related ocular adverse events
timeFrame: Up to 12 months
measure: Action taken with drug after ocular adverse event
timeFrame: Up to 12 months
measure: Clinical outcome of ocular adverse event
timeFrame: Up to 12 months
measure: Duration of ocular adverse events
timeFrame: Up to 12 months
measure: Duration of patient follow-up after ocular adverse event (in months)
timeFrame: Up to 12 months
measure: Number of non-ocular adverse events
timeFrame: Up to 12 months
measure: Number of serious non-ocular adverse events
timeFrame: Up to 12 months
measure: Seriousness reason for non-ocular adverse events
timeFrame: Up to 12 months
measure: Severity of non-ocular adverse events
timeFrame: Up to 12 months
measure: Number of treatment-related non-ocular adverse events
timeFrame: Up to 12 months
measure: Number of injection-related non-ocular adverse events
timeFrame: Up to 12 months
measure: Action taken with drug after non-ocular adverse event
timeFrame: Up to 12 months
measure: Clinical outcome of non-ocular adverse event
timeFrame: Up to 12 months
measure: Duration of non-ocular adverse events
timeFrame: Up to 12 months
measure: Duration of patient follow-up after non-ocular adverse event (in months)
timeFrame: Up to 12 months
Secondary outcomes:
measure: Total number of injections with intravitreal aflibercept per study eye
timeFrame: Up to 12 months
measure: Time between injections in the study eye (in days)
timeFrame: Up to 12 months
measure: Time between injections in the study eye and fellow eye (in days)
timeFrame: Up to 12 months
measure: Number of patients receiving bilateral treatment
timeFrame: Up to 18 months
Other outcomes:
Locations:
city: Multiple Locations
country: Mexico
facility: Many locations
Study officials:
References: