Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03908723
Other study ID # 21526
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 29, 2019
Est. completion date May 29, 2021

Study information

Verified date April 2019
Source Alexandria University
Contact Ahmed Abdel Hadi
Phone 00201288842558
Email aabdelhadi2010@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 6
Est. completion date May 29, 2021
Est. primary completion date March 29, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Panretinal photocoagulation
Intravitreal Aflibercept with PRP to the peripheral vascular lesions

Locations

Country Name City State
Egypt Alexandria university Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual acuity improvement 6 months after 3 consequative injections