NCT03908723

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2021

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

2 years

First QC Date

April 7, 2019

Last Update Submit

April 7, 2019

Conditions

Macular Edema Caused by Leber's Miliary Aneurysms

Outcome Measures

Primary Outcomes (1)

  • Visual acuity improvement

    6 months after 3 consequative injections

Study Arms (1)

all patients in the study

EXPERIMENTAL
Other: Panretinal photocoagulation

Interventions

Panretinal photocoagulationOTHER

Intravitreal Aflibercept with PRP to the peripheral vascular lesions

all patients in the study

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria university

Alexandria, 21311, Egypt

RECRUITING

Central Study Contacts

Ahmed Abdel Hadi

CONTACT

00201288842558aabdelhadi2010@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor ophthalmology Faculty of Medicine

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 9, 2019

Study Start

March 29, 2019

Primary Completion

March 29, 2021

Study Completion

May 29, 2021

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations

EG(1)