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: 19.0 Level: PT Classification code 10025415 Term: Macular oedema System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2014-003193-17-GB
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-27
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 160

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.
- Subject is willing, committed, and able to return for all clinic visits and complete all study-related procedures.
- Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 3 months after the last administration of study drug. The definition of adequate contraception will be based on the judgment of the investigator and on local requirements. Acceptable methods of contraception include, but are not limited to,
(i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intra-uterine device; (iv) hormone-based contraception. Subjects must agree to utilize two reliable and acceptable methods of contraception simultaneously.
- Negative pregnancy test (women of childbearing potential only
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.
- A history of vitreoretinal surgery in the study eye prior to Day 1 (Visit 2) or
anticipated within the 18 months following Day 1.
- Iris neovascularization, neovascularization or fibrosis of the iridocorneal angle, or vitreous hemorrhage in the study eye.
- History of vitreomacular traction in either the study eye or the fellow eye evident by biomicroscopic or OCT assessment that is considered by the investigator to affect central vision significantly.
- History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Any history of macular hole of stage 2 and above in the study eye.
- Prior trabeculectomy or other filtration surgery in the study eye.
- Uncontrolled glaucoma (defined as IOP more than 25 mm Hg despite treatment with antiglaucoma medication) in the study eye.
- Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a result of an yttrium aluminum garnet posterior capsulotomy) in the study eye.
- Previous therapeutic radiation in the region of the study eye.
- History of corneal transplant or corneal dystrophy in the study eye.
- Significant media opacities, including cataract, in the study eye that interfere with visual acuity or FP.
- History or clinical evidence of diabetic macular edema, AMD (neovascular AMD or geographic atrophy), BRVO, or any retinal vascular disease other than macular edema secondary to CRVO in either eye.
- Any history of uveitis in either eye.
- Presence of scleromalacia in either eye.
- Pregnancy or breastfeeding.

Study & Design

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