Overview

Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
0
Participant gender:
All
Summary
Phase 1, non-randomized, open label, noncomparative trial to study the effect of intravitreal injection of aflibercept on eyes with symptomatic macular edema from retinal artery macroaneurysms.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kamal Kishore, MD
Treatments:
Aflibercept
Criteria
Inclusion Criteria:

1. Symptomatic macular edema caused by RAM in one of the eyes. If both eyes are involved,
the eye with worse central foveal thickness will be enrolled in the study.

2. CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea

3. Best-corrected visual acuity of 73 to 24 letters.

4. Willing and able to comply with clinic visits and study-related procedures.

5. Willing to provide informed consent -

Exclusion Criteria:

1. Media opacity

2. pre-retinal fibrosis, retinal detachment, vitreo-macular traction

3. Infectious keratitis, conjunctivitis, blepharitis or scleritis

4. Any ocular surgery during the preceding 3 months.

5. aphakia or uncontrolled glaucoma

6. subfoveal hemorrhage

7. History of systemic or intravitreal anti-VEGF injections, intravitreal steroid
injection or implant, or laser treatment to RAM within six months

8. Any other ocular disease responsible for decrease in vision.

9. Concomitant ocular disease that can cause increase in foveal thickness

10. Ocular inflammation from any cause

11. Recent (<3 months) history of a thromboembolic event

12. Pregnant or breast feeding women.

13. Sexually active men or women of child bearing potential who are unwilling to practice
adequate contraception during the study.