Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
Status unconfirmed · Phase 1
Conditions studied: Macular Edema, Retinal Artery Macroaneurysm
In brief
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.
Key facts
- Study ID
- NCT02403128
- Run by
- Kamal Kishore, MD
- People needed
- 6
- Starts
- 2015-05-14
- Expected to finish
- 2020-02-01
- Last updated by the study team
- 2019-08-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
- Best-corrected visual acuity of 73 to 24 letters.
- Willing and able to comply with clinic visits and study-related procedures.
- Willing to provide informed consent -
You may not qualify if…
- Media opacity
- pre-retinal fibrosis, retinal detachment, vitreo-macular traction
- Infectious keratitis, conjunctivitis, blepharitis or scleritis
- Any ocular surgery during the preceding 3 months.
- aphakia or uncontrolled glaucoma
- subfoveal hemorrhage
- History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
- Any other ocular disease responsible for decrease in vision.
- Concomitant ocular disease that can cause increase in foveal thickness
- Ocular inflammation from any cause
- Recent (<3 months) history of a thromboembolic event
- Pregnant or breast feeding women.
- Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.
Where it is running
- Illinois Retina and Eye Associates — Peoria, Illinois, United States
Full record on ClinicalTrials.gov
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