Diabetic Macular EdemaNCT05496530
Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)
A study testing Suprachoroidal triamcinolone acetonide injection in people with Diabetic Macular Edema and Vogt Koyanagi Harada Disease, run by Benha University at 1 site in Egypt.
Trial summary
Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Macular Edema, Vogt Koyanagi Harada Disease, Retinal Vein Occlusion
- What is being tested?
- Suprachoroidal triamcinolone acetonide injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jul 2022to 15 Aug 2023
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
- Diabetic macular edema
- Vogt-koyanagi Harada disease
- Retinal vein occlusion.
Who cannot join
- other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
- Cases with confirmed diagnosis of glaucoma.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511
Ahmed A Tabl, 01222328766, ahmad4lg@gmail.com
ahmad4lg@gmail.com
About this study
Official title: One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases
Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.
Read the detailed description
In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.
- Being tested
- Suprachoroidal triamcinolone acetonide injection
- Medical subject headings
- Uveomeningoencephalitic Syndrome, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprachoroidal triamcinolone acetonide injectionDrug
Pars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic macular edema | Active comparator | Cases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography. Receives: Drug: Suprachoroidal triamcinolone acetonide injection |
| Vogt-koyanagi harada | Active comparator | Cases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography. Receives: Drug: Suprachoroidal triamcinolone acetonide injection |
| Retinal vein occlusion | Active comparator | Cases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography. Receives: Drug: Suprachoroidal triamcinolone acetonide injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Changes noted in vision after injection measured 8n logMar units by snellen chart.
Measured: Baseline and up to one year after injection.
Secondary outcomes (1)
Central macular thickness
Changes noted in central macular thickness after injection measured by optical coherence tomography in microns.
Measured: Baseline and up to one year after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start10 Jul 2022
- Primary completion30 Jul 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05496530
- Sponsor's protocol ID
- Rc-11-22
- Status last verified
- Aug 2022
- First submitted
- 9 Aug 2022
- Last updated
- 11 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Year Results for Suprachoroidal Triamcinolone Acetonide Injection in Various Retinal Diseases
- ClinicalTrials.gov ID
- NCT05496530
- Acronym / sponsor ID
- Rc-11-22
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Jul 2022 (actual)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 11 Aug 2022 (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.
Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.
Detailed description
In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diabetic macular edema | Active comparator | Drug: Suprachoroidal triamcinolone acetonide injectionCases with diabetic macular edema with central macular thickness more than 300 microns measured by optical coherence tomography. |
| Vogt-koyanagi harada | Active comparator | Drug: Suprachoroidal triamcinolone acetonide injectionCases with vogt-koyanagi harada and complicated with exudative retinal detachment confirmed by optical coherence tomography. |
| Retinal vein occlusion | Active comparator | Drug: Suprachoroidal triamcinolone acetonide injectionCases with retinal vein occlusion and complicated with macular edema confirmed by optical coherence tomography. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
- Diabetic macular edema
- Vogt-koyanagi Harada disease
- Retinal vein occlusion.
Key exclusion criteria (2 listed)
- other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
- Cases with confirmed diagnosis of glaucoma.
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 |
|---|---|---|
| Suprachoroidal triamcinolone acetonide injectionPars plana suprachoroidal injection of 4mg//0.1ml triamcinolone acetonide. | Drug | Diabetic macular edema, Retinal vein occlusion, Vogt-koyanagi harada |
Primary outcome
Visual acuity
Time frame: Baseline and up to one year after injection.
Changes noted in vision after injection measured 8n logMar units by snellen chart.
1 secondary outcome
Central macular thickness
Time frame: Baseline and up to one year after injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
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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.
Ahmed A Tabl principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suprachoroidal triamcinolone acetonide injection in people with Diabetic Macular Edema and Vogt Koyanagi Harada Disease, run by Benha 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 4 inclusion and 2 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 11 Aug 2022. 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 A Tabl (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Baseline and up to one year after injection.). 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 11 Aug 2022.