Evaluation of a Treat and Extend regimen of intravitreal aflibercept for macular edema secondary to CRVO

Phase 1

• Conditions: Macular edema secondary to CRVO; MedDRA version: 20.0Level: PTClassification code 10025415Term: Macular oedemaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-003193-17-IT
• Lead Sponsor: BAYER AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-07-31
• Study Start: 2021-02-09
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

- 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 128

Exclusion Criteria

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified