Back to resultsTreatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
Primary Purpose
Macular Edema Caused by Leber's Miliary Aneurysms
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Panretinal photocoagulation
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema Caused by Leber's Miliary Aneurysms
Eligibility Criteria
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:
-
Sites / Locations
- Alexandria universityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
all patients in the study
Arm Description
Outcomes
Primary Outcome Measures
Visual acuity improvement
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03908723
Brief Title
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
Official Title
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 29, 2019 (Actual)
Primary Completion Date
March 29, 2021 (Anticipated)
Study Completion Date
May 29, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema Caused by Leber's Miliary Aneurysms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
all patients in the study
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Panretinal photocoagulation
Intervention Description
Intravitreal Aflibercept with PRP to the peripheral vascular lesions
Primary Outcome Measure Information:
Title
Visual acuity improvement
Time Frame
6 months after 3 consequative injections
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdel Hadi
Phone
00201288842558
Ext
00201288842558
Email
aabdelhadi2010@gmail.com
Facility Information:
Facility Name
Alexandria university
City
Alexandria
ZIP/Postal Code
21311
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M EL Sayed
Phone
1288842558
Ext
1288842558
Email
aabdelhadi2010@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
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