Proliferative Diabetic Retinopathy - High RiskNCT06653361
Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy
A study testing Green laser in people with Proliferative Diabetic Retinopathy - High Risk, run by Hayatabad Medical Complex at 1 site in Pakistan.
Trial summary
Proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. The treatment options for proliferative diabetic retinopathy are anti-VEGF injection and retinal photocoagulation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy - High Risk
- What is being tested?
- Green laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2022to 28 Feb 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- proliferative diabetic retinopathy (PDR) with neovascularization on the disc or elsewhere in the retina
Who cannot join
- Participants with a history of previous history of:
- retinal photocoagulation
- vitreoretinal surgery
- tractional retinal detachment
- epiretinal membrane
- vitreomacular traction
Show all 10Show fewer
- glaucoma
- uveitis
- media opacities like cataract, corneal opacity, vitreous hemorrhage
- anti-VEGF injections in last 3 months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Khyber Teaching Hospital Peshawar
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
Proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. The treatment options for proliferative diabetic retinopathy are anti-VEGF injection and retinal photocoagulation. The study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.
- Being tested
- Green laser
- Keywords
- Diabetic retinopathy, Laser photocoagulation, Fluorescein angiography
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green laserProcedure or surgery
Green Laser
| Study group | Role | What they receive |
|---|---|---|
| TRP | Experimental | Targeted Retinal Photocoagulation Receives: Procedure: Green laser |
| PRP | Active comparator | Panretinal Photocoagulation Receives: Procedure: Green laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Best Corrected Visual Acuity
Measured: 2 months
CMT
Central Macular Thickness
Measured: 2 months
MD
Mean Deviation
Measured: 2 months
VFI
Visual Filed Index
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Sep 2022
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic Retinopathy - High RiskStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hayatabad Medical Complex
- Sponsor type
- Other government
- Collaborators
- Khyber Teaching Hospital
- Responsible party
- Principal investigator, Yousaf Jamal Mahsood, Hayatabad Medical Complex
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653361
- Sponsor's protocol ID
- 306/DME/KMC
- Status last verified
- Oct 2024
- First submitted
- 20 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-Widefield Fluorescein Angiography-Based Targeted Retinal Photocoagulation Versus Conventional Panretinal Photocoagulation in the Preservation of Visual Function and Regression of Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06653361
- Acronym / sponsor ID
- 306/DME/KMC
- Keywords
- Diabetic retinopathy, Laser photocoagulation, Fluorescein angiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Hayatabad Medical ComplexOther government
- Collaborators
- Khyber Teaching Hospital
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 22 Oct 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.
Proliferative diabetic retinopathy is a vision-threatening disease that can lead to irreversible visual loss. The treatment options for proliferative diabetic retinopathy are anti-VEGF injection and retinal photocoagulation. The study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRP | Experimental | Procedure: Green laserTargeted Retinal Photocoagulation |
| PRP | Active comparator | Procedure: Green laserPanretinal Photocoagulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- proliferative diabetic retinopathy (PDR) with neovascularization on the disc or elsewhere in the retina
Key exclusion criteria (10 listed)
- Participants with a history of previous history of:
- retinal photocoagulation
- vitreoretinal surgery
- tractional retinal detachment
- epiretinal membrane
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 |
|---|---|---|
| Green laserGreen Laser | Procedure or surgery | PRP, TRP |
Primary outcome
BCVA
Time frame: 2 months
Best Corrected Visual Acuity
CMT
Time frame: 2 months
Central Macular Thickness
MD
Time frame: 2 months
Mean Deviation
VFI
Time frame: 2 months
Visual Filed Index
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Green laser in people with Proliferative Diabetic Retinopathy - High Risk, run by Hayatabad Medical Complex 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 23 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BCVA (time frame: 2 months). The study lists 4 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 23 Oct 2024.