Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation

April 7, 2019 updated by: Ahmed M. Abdel Hadi, Alexandria University
This study evaluates the effectiveness of intravitreal Aflibercept (IVA) injection therapy, combined with peripheral laser photocoagulation, in the treatment of macular edema caused by Leber's miliary aneurysm. We believe that our study makes a significant contribution to the literature because to our knowledge, it is the first to report cases, in which IVA injection therapy was used to treat this condition.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

6

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Egypt
      • Alexandria, Egypt, 21311
        • Recruiting
        • Alexandria University
        • Contact:

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

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • FA revealed many aneurysms with leakage in the temporal mid-peripheral retina and near the macula. Optical coherence tomography (OCT) showed moderate to marked cystoid macular edema and subretinal fluid. There were no abnormal findings in the cornea, anterior chamber, or lens. No particular lesions were found in the opposite eye of each subject. Based on these findings, the patients were diagnosed with Leber's miliary aneurysm.

Exclusion Criteria:

-

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: all patients in the study
Other: Panretinal photocoagulation
Intravitreal Aflibercept with PRP to the peripheral vascular lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity improvement
Time Frame: 6 months after 3 consequative injections
6 months after 3 consequative injections

Collaborators and Investigators

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

Sponsor

Alexandria University

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)

March 29, 2019

Primary Completion (Anticipated)

March 29, 2021

Study Completion (Anticipated)

May 29, 2021

Study Registration Dates

First Submitted

April 7, 2019

First Submitted That Met QC Criteria

April 7, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 9, 2019

Last Update Submitted That Met QC Criteria

April 7, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21526

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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