Intravitreal Aflibercept Injection for Symptomatic Macular Edema From Retinal Artery Macroaneurysms

August 6, 2019 updated by: Kamal Kishore, MD
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Retina and Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in best-corrected ETDRS visual acuity at 3 and 6 months.
Time Frame: six months.
six months.
Change in central field macular thickness at 3 and 6 months
Time Frame: six months
six months
Proportion of eyes completely dry by spectral domain OCT
Time Frame: six months
six months
Occlusion of retinal artery macroaneurysm (RAM) at 3 and 6 months by intravenous fluorescein angiography
Time Frame: six months
six months
Number of patients requiring additional treatment beyond baseline and total number of treatments
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kamal Kishore, MD

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2015

Primary Completion (Anticipated)

February 1, 2020

Study Completion (Anticipated)

February 1, 2020

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

March 31, 2015

Study Record Updates

Last Update Posted (Actual)

August 8, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Kishore_Eylea_RAM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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