Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

• Sponsor: Kamal Kishore, MD (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02403128
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 56.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema; Retinal Artery Macroaneurysm	Drug: aflibercept	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
• Actual Study Start Date: May 14, 2015
• Anticipated Primary Completion Date: Feb 1, 2020
• Anticipated Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients with macular edema from RAM 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.	Drug: aflibercept; 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.; Other Names: Eylea

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Change in best-corrected ETDRS visual acuity at 3 and 6 months. [six months.]

2. Change in central field macular thickness at 3 and 6 months [six months]

3. Proportion of eyes completely dry by spectral domain OCT [six months]

4. Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography [six months]

5. Number of patients requiring additional treatment beyond baseline and total number of treatments [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Illinois Retina and Eye Associates	Peoria	Illinois	United States	61615

Sponsors and Collaborators

• Kamal Kishore, MD

Investigators

• Principal Investigator: Kamal Kishore, MD, Illinois Retina and Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kamal Kishore, MD, Principal Investigator, Illinois Retina and Eye Associates
• ClinicalTrials.gov Identifier: NCT02403128
• Other Study ID Numbers: Kishore_Eylea_RAM
• First Posted: Mar 31, 2015
• Last Update Posted: Aug 8, 2019
• Last Verified: Aug 1, 2019

• Keywords provided by Kamal Kishore, MD, Principal Investigator, Illinois Retina and Eye Associates: 362.17
• Additional relevant MeSH terms: Macular Edema; Edema; Aflibercept

Study Results

No Results Posted as of Aug 8, 2019