Macular Edema, Retinal Artery Macroaneurysm
Conditions
Keywords
362.17
Brief 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.
Detailed description
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.
Interventions
DRUGaflibercept
Intravitreal injection of 2.0 mg aflibercept at baseline, and repeated no sooner than two months from the previous injection for persistent macular edema as defined in the protocol.
Sponsors
Kamal Kishore, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety profile as demonstrated by the incidence and severity of ocular and systemic adverse events in patients with macular edema caused by retina artery macroaneurysm(s) after intravitreal injection of 2 mg of aflibercept | six months |
Secondary
| Measure | Time frame |
|---|---|
| Change in best-corrected ETDRS visual acuity at 3 and 6 months. | six months. |
| Change in central field macular thickness at 3 and 6 months | six months |
| Proportion of eyes completely dry by spectral domain OCT | six months |
| Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography | six months |
| Number of patients requiring additional treatment beyond baseline and total number of treatments | six months |
Countries
United States
Outcome results
None listed