Status:
COMPLETED
Evaluation of a Treat and Extend Regimen of Intravitreal Aflibercept for Macular Edema Secondary to CRVO
Lead Sponsor:
Bayer
Conditions:
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Central retinal vein occlusion (CRVO) occurs when the main blood vessel that transports blood away from the retina (the very back portion of the eye) becomes blocked, causing the leakage of fluid into...
Eligibility Criteria
Inclusion
- Center-involved macular edema secondary to CRVO for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit).
- Adult subjects diagnosed with macular edema secondary to CRVO who are scheduled to be treated with IVT aflibercept as per investigator's routine treatment practice with the intent to use a T\&E regimen after initial dosing.
- Treatment-naïve subjects for macular edema secondary to CRVO.
- Men and women ≥ 18 years of age.
- Documented BCVA of ETDRS letter score of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320) in the study eye.
Exclusion
- Previous PRP or macular laser photocoagulation in the study eye.
- Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for macular edema secondary to RVO, except dietary supplements or vitamins prior to inclusion in the study. Intraocular anti-VEGF treatment is permitted for the treatment of diseases of fellow eye except for those that are specifically excluded.
- Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study.
- Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1.
- Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening.
- Any history of allergy to povidone iodine.
- Known serious allergy to the fluorescein sodium for injection in angiography.
- Presence of any contraindications indicated in the EU commission/locally approved label for IVT aflibercept: hypersensitivity to the active substance IVT aflibercept or to any of the excipients; active or suspected ocular or periocular infection; active severe intraocular inflammation.
Key Trial Info
Start Date :
June 10 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT02800642
Start Date
June 10 2016
End Date
July 31 2019
Last Update
July 8 2020
Active Locations (42)
Enter a location and click search to find clinical trials sorted by distance.
1
Albury, New South Wales, Australia, 2640
2
Sydney, New South Wales, Australia, 2000
3
Parramatta, Australia, 2150
4
Calgary, Alberta, Canada, T2H 0C8