Clinical trial NCT02403128: Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
Official title: Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Macular Edema
Retinal Artery Macroaneurysm
Keywords: 362.17
Lead sponsor: Illinois Retina and Eye Associates
Sponsor class: OTHER
First posted: 2015-03-31
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: six months
Secondary outcomes:
measure: Change in best-corrected ETDRS visual acuity at 3 and 6 months.
timeFrame: six months.
measure: Change in central field macular thickness at 3 and 6 months
timeFrame: six months
measure: Proportion of eyes completely dry by spectral domain OCT
timeFrame: six months
measure: Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography
timeFrame: six months
measure: Number of patients requiring additional treatment beyond baseline and total number of treatments
timeFrame: six months
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Illinois Retina and Eye Associates
state: Illinois
Study officials:
affiliation: Illinois Retina and Eye Associates
name: Kamal Kishore, MD
role: PRINCIPAL_INVESTIGATOR
References: