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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with macular edema from RAM | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept | Drug | 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Kishore, MD | Illinois Retina and Eye Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois Retina and Eye Associates | Peoria | Illinois | 61615 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 3, 2020 | |
| Reset | Aug 14, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 3, 2020 | Aug 14, 2020 |
| ID | Term |
|---|---|
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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|
| 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 |