Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

Kamal Kishore, MD

Status and phase: Unknown; Phase 1

Conditions: Macular Edema; Retinal Artery Macroaneurysm

Treatments: Drug: aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT02403128

Kishore_Eylea_RAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Patients with macular edema from RAM

Experimental group

Description:

Intravitreal aflibercept 2.0 mg injection for eyes meeting eligibility criteria will be administered at baseline. Reinjection of the drug for protocol-defined criteria at least two months after previous injection.

Treatment:

Drug: aflibercept