check_circleStudy Completed

Retinal disease

Bayer Identifier:

19212

ClinicalTrials.gov Identifier:

NCT04137120

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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

  • - 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
February 2021 - February 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, Mexico

Primary Outcome

  • Number of ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Number of serious ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Seriousness reason for ocular adverse events
    Seriousness 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.
    date_rangeTime Frame:
    Up to 12 months
  • Severity of ocular adverse events
    The severity of adverse events is classified as mild, moderate or severe by treating physician.
    date_rangeTime Frame:
    Up to 12 months
  • Number of treatment-related ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Number of injection-related ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Action taken with drug after ocular adverse event
    Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
    date_rangeTime Frame:
    Up to 12 months
  • Clinical outcome of ocular adverse event
    Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
    date_rangeTime Frame:
    Up to 12 months
  • Duration of ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Duration of patient follow-up after ocular adverse event (in months)
    date_rangeTime Frame:
    Up to 12 months
  • Number of non-ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Number of serious non-ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Seriousness reason for non-ocular adverse events
    Seriousness 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.
    date_rangeTime Frame:
    Up to 12 months
  • Severity of non-ocular adverse events
    The severity of adverse events is classified as mild, moderate or severe by treating physician.
    date_rangeTime Frame:
    Up to 12 months
  • Number of treatment-related non-ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Number of injection-related non-ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Action taken with drug after non-ocular adverse event
    Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
    date_rangeTime Frame:
    Up to 12 months
  • Clinical outcome of non-ocular adverse event
    Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
    date_rangeTime Frame:
    Up to 12 months
  • Duration of non-ocular adverse events
    date_rangeTime Frame:
    Up to 12 months
  • Duration of patient follow-up after non-ocular adverse event (in months)
    date_rangeTime Frame:
    Up to 12 months

Secondary Outcome

  • Total number of injections with intravitreal aflibercept per study eye
    date_rangeTime Frame:
    Up to 12 months
  • Time between injections in the study eye (in days)
    date_rangeTime Frame:
    Up to 12 months
  • Time between injections in the study eye and fellow eye (in days)
    date_rangeTime Frame:
    Up to 12 months
  • Number of patients receiving bilateral treatment
    date_rangeTime Frame:
    Up to 18 months

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
N/A