Diabetic Macular EdemaNCT06449768
Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema
An observational study of Diabetic Macular Edema, run by Superior University at 1 site in Pakistan.
Trial summary
It will investigate a novel treatment approach for diabetic macular edema (DME), which causes vision impairment in diabetic patients. It will focuse on the efficacy and safety of administering triamcinolone acetonide via suprachoroidal injection, targeting the space between the sclera and choroid. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Diabetic Macular Edema
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2023to 28 Oct 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic Macular Edema patient having Diabetes for more than 2 years
Who may be able to join
- Above 30 years old patients male and female
- Diabetic patient
- Diabetic patient for more than 2 years
- Macular thickness of more than 280um
Who cannot join
- Patient below 30 years
- Patients having media opacity
- Patients with other systemic problems
- Uncooperative patients
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lions Medical Complex , Main Market, Gulberg ll
Lahore, Punjab Province
About this study
It will investigate a novel treatment approach for diabetic macular edema (DME), which causes vision impairment in diabetic patients. It will focuse on the efficacy and safety of administering triamcinolone acetonide via suprachoroidal injection, targeting the space between the sclera and choroid.
Read the detailed description
This method aims to enhance drug delivery to the retina, potentially improving outcomes compared to conventional treatments. Participants receive suprachoroidal injections, and the study measures changes in macular thickness and visual acuity. The study's findings could offer a promising alternative to existing DME treatments, aiming to provide better management of the condition and improved patient quality of life.
- Conditions
- Diabetic Macular Edema
- Being tested
- Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetic Macular EdemaBehavioural
observing the eye behavior in Diabetic Macular Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity Testing
Visual acuity testing evaluates the participants' ability to discern letters or symbols at a standardized distance, providing a measure of vision clarity. This tool helps determine the functional improvement in vision.
Measured: 12 Months
Optical Coherence Tomography
OCT is employed to assess changes in macular thickness, providing detailed cross-sectional images of the retina. This non-invasive imaging technique helps quantify the extent of macular edema and monitoring
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start1 Nov 2023
- Primary completion1 May 2024
- Study completion28 Oct 2024 (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 Superior 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449768
- Sponsor's protocol ID
- MSRSW/Batch-Fall22/719
- Status last verified
- Jun 2024
- First submitted
- 25 May 2024
- Last updated
- 10 Jun 2024
- 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 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Suprachoroidal Injection In Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT06449768
- Acronym / sponsor ID
- MSRSW/Batch-Fall22/719
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 28 Oct 2024 (estimated)
- First posted
- 10 Jun 2024 (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.
It will investigate a novel treatment approach for diabetic macular edema (DME), which causes vision impairment in diabetic patients. It will focuse on the efficacy and safety of administering triamcinolone acetonide via suprachoroidal injection, targeting the space between the sclera and choroid.
Detailed description
This method aims to enhance drug delivery to the retina, potentially improving outcomes compared to conventional treatments. Participants receive suprachoroidal injections, and the study measures changes in macular thickness and visual acuity. The study's findings could offer a promising alternative to existing DME treatments, aiming to provide better management of the condition and improved patient quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic Macular Edema patient having Diabetes for more than 2 years
Key inclusion criteria (4 listed)
- Above 30 years old patients male and female
- Diabetic patient
- Diabetic patient for more than 2 years
- Macular thickness of more than 280um
Key exclusion criteria (4 listed)
- Patient below 30 years
- Patients having media opacity
- Patients with other systemic problems
- Uncooperative patients
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 |
|---|---|---|
| Diabetic Macular Edemaobserving the eye behavior in Diabetic Macular Edema | Behavioural | – |
Primary outcome
Visual Acuity Testing
Time frame: 12 Months
Visual acuity testing evaluates the participants' ability to discern letters or symbols at a standardized distance, providing a measure of vision clarity. This tool helps determine the functional improvement in vision.
Optical Coherence Tomography
Time frame: 12 months
OCT is employed to assess changes in macular thickness, providing detailed cross-sectional images of the retina. This non-invasive imaging technique helps quantify the extent of macular edema and monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Diabetic Macular Edema
Active, not recruitingObservational study
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Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
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RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Superior University at 1 site in Pakistan.
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 4 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 10 Jun 2024. 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 Pakistan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity Testing (time frame: 12 Months). 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 10 Jun 2024.