Retina; ChangeNCT05288192
Changes After Suprachoroidal Injection.
A study testing Suprachoroidal triamcinolone acetonide (SCTA) injection in people with Retina; Change and Intraocular Pressure, run by Benha University at 1 site in Egypt.
Trial summary
Changes after suprachoroidal injection are analyzed for statistical analysis. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Retina; Change, Intraocular Pressure, Cataract
- What is being tested?
- Suprachoroidal triamcinolone acetonide (SCTA) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 1 Sep 2022
- 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
- Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.
- Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.
Who cannot join
- Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.
- Choroidal neovascularization that require anti-vascular endothelial growth factors.
- Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Benha University
Banhā, QA, 13511
Ahmed Abdelshafy, MD, 01222328766, ahmad4lg@gmail.com
ahmad4lg@gmail.com
About this study
Official title: Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.
Changes after suprachoroidal injection are analyzed for statistical analysis.
Read the detailed description
Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.
- Conditions
- Retina; Change, Intraocular Pressure, Cataract, Macular Edema
- Being tested
- Suprachoroidal triamcinolone acetonide (SCTA) injection
- Medical subject headings
- Cataract, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suprachoroidal triamcinolone acetonide (SCTA) injectionDrug
Also called SCTA injection
Suprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide.
| Study group | Role | What they receive |
|---|---|---|
| Suprachoroidal triamcinolone injection | Active comparator | Eyes treated with suprachoroidal injection of triamcinolone acetonide. Receives: Drug: Suprachoroidal triamcinolone acetonide (SCTA) injection |
| Non-treated eyes | No intervention | Eyes that are receiving no interventions during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in visual acuity
Changes in best corrected visual acuity after injection
Measured: Monthly after injection till six months of follow up
Changes in central foveal thickness
Changes in central macular thickness after injection
Measured: Monthly after injection till six months of follow up
Secondary outcomes (2)
Changes in intraocular pressure
Changes in intraocular pressure after injection
Measured: Monthly after injection till six months of follow up
Changes in lens
Cataract progression after injection
Measured: Monthly after injection till six months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start15 Feb 2022
- Primary completion30 Aug 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retina; ChangeStudies of the same condition, open and under way.
- 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
- 30 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, MD, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288192
- Sponsor's protocol ID
- Rc-3-22
- Status last verified
- Mar 2022
- First submitted
- 11 Mar 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- 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 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes Noted After Suprachoroidal Triamcinolone Acetonide Injection.
- ClinicalTrials.gov ID
- NCT05288192
- Acronym / sponsor ID
- Rc-3-22
- Conditions
- Retina; Change, Intraocular Pressure, Cataract, Macular Edema
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 21 Mar 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.
Changes after suprachoroidal injection are analyzed for statistical analysis.
Detailed description
Changes after suprachoroidal injection of triamcinolone acetonide are noted in various retinal diseases treated by this technique to address its effects over six months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suprachoroidal triamcinolone injection | Active comparator | Drug: Suprachoroidal triamcinolone acetonide (SCTA) injectionEyes treated with suprachoroidal injection of triamcinolone acetonide. |
| Non-treated eyes | No intervention | –Eyes that are receiving no interventions during the study period. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients prepared to suprachoroidal injection for various retinal diseases will be enrolled in the study.
- Bilateral retinal diseases that required interventions as diabetic macular edema, exudative retinal detachment, and serous chorioretinopathies.
Key exclusion criteria (3 listed)
- Other retinal diseases that are not expected to improve after steroid injections as central retinal artery occlusion and age-related macular degenerations.
- Choroidal neovascularization that require anti-vascular endothelial growth factors.
- Patients refused to have steroid injections even after discussing the nature of their disease with them and the procedure to be done.
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 (SCTA) injectionAlso: SCTA injectionSuprachoroidal injection of 4mg/0.1ml of triamcinolone acetonide. | Drug | Suprachoroidal triamcinolone injection |
Primary outcome
Changes in visual acuity
Time frame: Monthly after injection till six months of follow up
Changes in best corrected visual acuity after injection
Changes in central foveal thickness
Time frame: Monthly after injection till six months of follow up
Changes in central macular thickness after injection
2 secondary outcomes
Changes in intraocular pressure
Time frame: Monthly after injection till six months of follow up
Changes in lens
Time frame: Monthly after injection till six months of follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 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 Tabl, 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 study testing Suprachoroidal triamcinolone acetonide (SCTA) injection in people with Retina; Change and Intraocular Pressure, 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 2 inclusion and 3 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 21 Mar 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 Abdelshafy (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in visual acuity (time frame: Monthly after injection till six months of follow up). The study lists 2 primary outcomes in all. 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 21 Mar 2022.