Central Serous ChorioretinopathyPhase 2/3NCT05337332
Results of Suprachoroidal Steroids Injections in Two Chorioretinal Diseases
A Phase 2/3 study testing Triamcinolone Acetonide in people with Central Serous Chorioretinopathy and Irvine-Gass Syndrome, run by Benha University at 1 site in Egypt.
Trial summary
Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Central Serous Chorioretinopathy, Irvine-Gass Syndrome, Pars Planitis
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Apr 2022to 1 Jun 2023
- Phase
- Phase 2/3
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.
Who cannot join
- other retinal diseases that may affect CMT and final visual outcome.
- Patients with dense corneal opacity.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy
Banhā, QA, 13511
Ahmed Abdelshafy, 01222328766, ahmad4lg@gmail.com
About this study
Official title: Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results
Suprachoroidal injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.
Read the detailed description
Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.
- Conditions
- Central Serous Chorioretinopathy, Irvine-Gass Syndrome, Pars Planitis, Cystoid Macular Edema
- Being tested
- Triamcinolone Acetonide
- Keywords
- Central serous chorioretinopathy, Cystoid macular edema
- Medical subject headings
- Central Serous Chorioretinopathy, Macular Edema, Pars Planitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Suprachoroidal triamcinolone acetonide injection (SCTA)
Suprachoroidal injection of triamcinolone acetonide
| Study group | Role | What they receive |
|---|---|---|
| Central serous chorioretinopathy group | Experimental | Cases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide. Receives: Drug: Triamcinolone Acetonide |
| Irvine-Gass Syndrome group | Experimental | Cases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central macular thickness
Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)
Measured: Baseline and 12 months after injection.
Secondary outcomes (1)
Best corrected visual acuity
Changes in best corrected visual acuity (BCVA) measured in logarithm of minimal angle of resolution (LogMAR) by chart projector.
Measured: Baseline and 12 months after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start14 Apr 2022
- Primary completion30 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Serous ChorioretinopathyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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 Abdelshafy, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337332
- Sponsor's protocol ID
- RC 7-7-22
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprachoroidal Triamcinolone Acetonide Injection in Two Chorioretinal Diseases: One Year Results
- ClinicalTrials.gov ID
- NCT05337332
- Acronym / sponsor ID
- RC 7-7-22
- Conditions
- Central Serous Chorioretinopathy, Irvine-Gass Syndrome, Pars Planitis, Cystoid Macular Edema
- Keywords
- Central serous chorioretinopathy, Cystoid macular edema
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 20 Apr 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 injection is a safe way for intraocular drug delivery. It was used to treat various retinal conditions.
Detailed description
Suprachoroidal triamcinolone acetonide injection is used to treat various retinal diseases, higher concentration of the injected material is found when the suprachoroidal space is used as an intraocular delivery pathway when compared to the conventional intravitreal pathway.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central serous chorioretinopathy group | Experimental | Drug: Triamcinolone AcetonideCases with central serous chorioretinopathy (CSR) that will be injected with suprachoroidal triamcinolone acetonide. |
| Irvine-Gass Syndrome group | Experimental | Drug: Triamcinolone AcetonideCases with cystoid macular edema due to irvine-gass syndrome that will be injected with suprachoroidal triamcinolone acetonide |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed as central serous chorioretinopathy and patients with cystoid macular edema due to irvine-gass syndrome after cataract surgery.
Key exclusion criteria (2 listed)
- other retinal diseases that may affect CMT and final visual outcome.
- Patients with dense corneal opacity.
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 |
|---|---|---|
| Triamcinolone AcetonideAlso: Suprachoroidal triamcinolone acetonide injection (SCTA)Suprachoroidal injection of triamcinolone acetonide | Drug | Central serous chorioretinopathy group, Irvine-Gass Syndrome group |
Primary outcome
Central macular thickness
Time frame: Baseline and 12 months after injection.
Changes in central macular thickness (CMT) measured in millimeters (mm) by optical coherence tomography (OCT)
1 secondary outcome
Best corrected visual acuity
Time frame: Baseline and 12 months after injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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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 Abdelshafy, MD 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 Phase 2/3 study testing Triamcinolone Acetonide in people with Central Serous Chorioretinopathy and Irvine-Gass Syndrome, 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 1 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 20 Apr 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Abdelshafy, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central macular thickness (time frame: Baseline and 12 months 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 20 Apr 2022.