Peoria, Illinois 61615


Purpose:

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.


Study summary:

Baseline evaluation will consist of measurement of best-corrected ETDRS visual acuity, complete eye exam, including IOP measurement, color photos and intravenous fluorescein angiography, spectral domain OCT and vitals. Patients meeting eligibility criteria will be treated with an intravitreal injection of 2.0 mg aflibercept under usual aseptic precautions. Follow up visits will be on Day 7, 30, 60, 90, 120, 150 and 180. At each follow-up visit, best-corrected ETDRS visual acuity, IOP measurement and central foveal thickness (CFT) by SDOCT will be obtained. Color photos and IVFA will be performed at month 3 and 6 visits. Retreatment shall be performed no sooner than two months after previous injection for one or more the following criteria 1. CFT >310 microns 2. Intraretinal or subretinal fluid on SDOCT 3. Increase in CFT by 50 or more microns from the lowest value observed after intravitreal aflibercept injection 4. Decrease in vision by 5 or more letters frpm the previous visit associated with OCT evidence of macular edema. 5. Appearance of new hemorrhage on color photographs. Final follow-up will be at six months. Data collected will include, change in ETDRS visual acuity from the baseline, change in CFT, number of injections, number of eyes completely dry by SDOCT, and number of eyes with a thrombosed RAM by IVFA.


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.


NCT ID:

NCT02403128


Primary Contact:

Principal Investigator
Kamal Kishore, MD
Illinois Retina and Eye Associates

Kamal Kishore, MD
Phone: 309-589-1880
Email: kamal.kishore1963@gmail.com


Backup Contact:

N/A


Location Contact:

Peoria, Illinois 61615
United States

Kamal Kishore, MD
Phone: 309-589-1880
Email: kamal.kishore1963@gmail.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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