Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
Primary Purpose
Macular Edema, Retinal Artery Macroaneurysm
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring 362.17
Eligibility Criteria
Inclusion Criteria:
- 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.
- CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
- Best-corrected visual acuity of 73 to 24 letters.
- Willing and able to comply with clinic visits and study-related procedures.
- Willing to provide informed consent -
Exclusion Criteria:
- Media opacity
- pre-retinal fibrosis, retinal detachment, vitreo-macular traction
- Infectious keratitis, conjunctivitis, blepharitis or scleritis
- Any ocular surgery during the preceding 3 months.
- aphakia or uncontrolled glaucoma
- subfoveal hemorrhage
- History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
- Any other ocular disease responsible for decrease in vision.
- Concomitant ocular disease that can cause increase in foveal thickness
- Ocular inflammation from any cause
- Recent (<3 months) history of a thromboembolic event
- Pregnant or breast feeding women.
- Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.
Sites / Locations
- Illinois Retina and Eye Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with macular edema from RAM
Arm 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in best-corrected ETDRS visual acuity at 3 and 6 months.
Change in central field macular thickness at 3 and 6 months
Proportion of eyes completely dry by spectral domain OCT
Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography
Number of patients requiring additional treatment beyond baseline and total number of treatments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02403128
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2015 (Actual)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kamal Kishore, MD
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Retinal Artery Macroaneurysm
Keywords
362.17
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with macular edema from RAM
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Time Frame
six months
Secondary Outcome Measure Information:
Title
Change in best-corrected ETDRS visual acuity at 3 and 6 months.
Time Frame
six months.
Title
Change in central field macular thickness at 3 and 6 months
Time Frame
six months
Title
Proportion of eyes completely dry by spectral domain OCT
Time Frame
six months
Title
Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography
Time Frame
six months
Title
Number of patients requiring additional treatment beyond baseline and total number of treatments
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
CFT of 310 microns or more by spectral domain OCT or lipid in the center of the fovea
Best-corrected visual acuity of 73 to 24 letters.
Willing and able to comply with clinic visits and study-related procedures.
Willing to provide informed consent -
Exclusion Criteria:
Media opacity
pre-retinal fibrosis, retinal detachment, vitreo-macular traction
Infectious keratitis, conjunctivitis, blepharitis or scleritis
Any ocular surgery during the preceding 3 months.
aphakia or uncontrolled glaucoma
subfoveal hemorrhage
History of systemic or intravitreal anti-VEGF injections, intravitreal steroid injection or implant, or laser treatment to RAM within six months
Any other ocular disease responsible for decrease in vision.
Concomitant ocular disease that can cause increase in foveal thickness
Ocular inflammation from any cause
Recent (<3 months) history of a thromboembolic event
Pregnant or breast feeding women.
Sexually active men or women of child bearing potential who are unwilling to practice adequate contraception during the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamal Kishore, MD
Organizational Affiliation
Illinois Retina and Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois Retina and Eye Associates
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms
We'll reach out to this number within 24 hrs