Macular Edema Caused by Leber's Miliary AneurysmsNCT03908723
Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
A study testing Panretinal photocoagulation in people with Macular Edema Caused by Leber's Miliary Aneurysms, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Macular Edema Caused by Leber's Miliary Aneurysms
- What is being tested?
- Panretinal photocoagulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Mar 2019to 29 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria, 21311
Ahmed M EL Sayed, 1288842558 ext. 1288842558, aabdelhadi2010@gmail.com
About this study
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.
- Being tested
- Panretinal photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal photocoagulationOther
Intravitreal Aflibercept with PRP to the peripheral vascular lesions
| Study group | Role | What they receive |
|---|---|---|
| all patients in the study | Experimental | Not described Receives: Other: Panretinal photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity improvement
Measured: 6 months after 3 consequative injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start29 Mar 2019
- Primary completion29 Mar 2021 (estimated)
- Study completion29 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Edema Caused by Leber's Miliary AneurysmsStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed M. Abdel Hadi, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908723
- Sponsor's protocol ID
- 21526
- Status last verified
- Apr 2019
- First submitted
- 7 Apr 2019
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Macular Edema Caused by Leber's Miliary Aneurysms Using Intravitreal Aflibercept and Peripheral Laser Photocoagulation
- ClinicalTrials.gov ID
- NCT03908723
- Acronym / sponsor ID
- 21526
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 29 Mar 2019 (actual)
- Primary completion
- 29 Mar 2021 (estimated)
- Study completion
- 29 May 2021 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients in the study | Experimental | Other: Panretinal photocoagulation |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Panretinal photocoagulationIntravitreal Aflibercept with PRP to the peripheral vascular lesions | Other | all patients in the study |
Primary outcome
Visual acuity improvement
Time frame: 6 months after 3 consequative injections
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Panretinal photocoagulation in people with Macular Edema Caused by Leber's Miliary Aneurysms, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abdel Hadi (00201288842558 ext. 00201288842558, aabdelhadi2010@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity improvement (time frame: 6 months after 3 consequative injections). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.