Diabetic RetinopathyNCT06821633
Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
A study testing Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography) in people with Diabetic Retinopathy, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2025to 7 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Type 1 or Type 2 diabetes mellitus
- Clinical dilated fundus examination and Optos imaging within 7 fields showing diabetic retinopathy (DR) lesions no more severe than severe non-proliferative diabetic retinopathy (NPDR)
- Optical coherence tomography angiography (OCTA) demonstrating non-perfusion (NP) areas greater than 1 disc diameter (PD) in both eyes
- Diabetic retinopathy in both eyes at the same stage, with the total NP area within the observed range of OCTA being comparable (difference less than 5 PD)
- Absence of other ocular diseases that could lead to the formation of retinal microaneurysms
Show all 12Show fewer
- Absence of other ocular diseases that could lead to the formation of retinal non-perfusion areas
- No diabetic macular edema involving the fovea
- No history of retinal laser treatment
- No history of intravitreal injection therapy within the past 3 months
- No history of ocular surgery other than cataract surgery
- Ability to cooperate with all examinations and provide informed consent
Who cannot join
- Optical media opacity affecting OCTA imaging
- Patients with difficulties in cooperating with laser treatment
- Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases
- Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces
- Patients requiring early PRP (conditions include: combined DME, planned cataract surgery, pregnancy planning, early PDR, poor follow-up compliance, severe vision loss in the other eye, poor glycemic control, poor renal function, or type 1 diabetes)
- FFA showing NP greater than 10 PD within the ETDRS area or a total NP area greater than 75 PD, or an ischemia index greater than 35%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610014
Jie Li, doctor, +86 13908094675, lijieyk@med.uestc.edu.cn
About this study
This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. From February 2025 to August 2026, 30 diabetic patients attending the Ophthalmology Department of Sichuan Provincial People's Hospital will be enrolled. Using a simple randomization method, one eye of each patient will be assigned to the intervention group, while the contralateral eye will serve as the control, resulting in 30 eyes in each group. The intervention group will undergo OCTA-guided selective photocoagulation, specifically using a grid pattern (3x3) of spot laser applied once to the NP area, extending one spot diameter beyond the NP boundary. Each session will last 10-20 minutes. The control group will receive no treatment. The study will compare changes in NP area, DR grading progression, and control of other DR lesions at 3, 6, 9, and 12 months between the two groups.
- Conditions
- Diabetic Retinopathy
- Being tested
- Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography 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.
Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)Procedure or surgery
The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital | Experimental | The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes. Receives: Procedure: Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography) |
| Eyes with NPDR that were diagnosed at our hospital | No intervention | Perform the same examination but administer no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months
Measured: From enrollment to reexamination at 0,3,6,9, and 12 months
Secondary outcomes (4)
The number of microaneurysms, intraretinal microvascular abnormalities (IRMA) in both groups of eyes at 0, 3, 6, 9, and 12 months
Measured: From enrollment to reexamination at 0,3,6,9, and 12 months
The number of neovascularization (NV) in both groups of eyes at 0, 3, 6, 9, and 12 months
Measured: From enrollment to reexamination at 0,3,6,9, and 12 months
Area of foveal avascular zone (FAZ) at 0, 3, 6, 9, and 12 months in two groups of eyes
Measured: From enrollment to reexamination at 0,3,6,9, and 12 months
DR grading at 0, 3, 6, 9, and 12 months in two groups of eyes
Measured: From enrollment to reexamination at 0,3,6,9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start7 Jul 2025 (estimated)
- Primary completion7 Aug 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jie Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821633
- Sponsor's protocol ID
- 2024-KY740-1
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2030, via https://pan.baidu.com
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Retardation Effect of OCTA-Guided Targeted Photocoagulation on the Progression of Non-Perfusion Areas in Diabetic Retinopathy Patients
- ClinicalTrials.gov ID
- NCT06821633
- Acronym / sponsor ID
- 2024-KY740-1
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Study start
- 7 Jul 2025 (estimated)
- Primary completion
- 7 Aug 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 12 Feb 2025 (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.
This study aims to evaluate the impact of widefield OCTA-guided selective photocoagulation on the progression of diabetic retinopathy (DR) by comparing the control of non-perfusion (NP) areas, DR grading, and management of other DR lesions. The study is designed as a parallel randomized controlled trial. From February 2025 to August 2026, 30 diabetic patients attending the Ophthalmology Department of Sichuan Provincial People's Hospital will be enrolled. Using a simple randomization method, one eye of each patient will be assigned to the intervention group, while the contralateral eye will serve as the control, resulting in 30 eyes in each group. The intervention group will undergo OCTA-guided selective photocoagulation, specifically using a grid pattern (3x3) of spot laser applied once to the NP area, extending one spot diameter beyond the NP boundary. Each session will last 10-20 minutes. The control group will receive no treatment. The study will compare changes in NP area, DR grading progression, and control of other DR lesions at 3, 6, 9, and 12 months between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital | Experimental | Procedure: Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes. |
| Eyes with NPDR that were diagnosed at our hospital | No intervention | –Perform the same examination but administer no treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years
- Type 1 or Type 2 diabetes mellitus
- Clinical dilated fundus examination and Optos imaging within 7 fields showing diabetic retinopathy (DR) lesions no more severe than severe non-proliferative diabetic retinopathy (NPDR)
- Optical coherence tomography angiography (OCTA) demonstrating non-perfusion (NP) areas greater than 1 disc diameter (PD) in both eyes
- Diabetic retinopathy in both eyes at the same stage, with the total NP area within the observed range of OCTA being comparable (difference less than 5 PD)
Key exclusion criteria (6 listed)
- Optical media opacity affecting OCTA imaging
- Patients with difficulties in cooperating with laser treatment
- Patients with renal failure, diabetic neuropathy, or severe cardiovascular diseases
- Patients who are unlikely to complete follow-ups every 3 months, as well as those residing in other provinces
- Patients requiring early PRP (conditions include: combined DME, planned cataract surgery, pregnancy planning, early PDR, poor follow-up compliance, severe vision loss in the other eye, poor glycemic control, poor renal function, or type 1 diabetes)
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 |
|---|---|---|
| Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography)The patient's eyes were first scanned using the Topcon OCTA (five-field montage) with a 24×20mm and a 6×6mm scan range. After enrollment, the patient underwent treatment on the same day in the retinal laser room. The laser treatment was performed by the same ophthalmologist. After obtaining baseline fundus images, the treating ophthalmologist overlaid the OCTA images onto the fundus images using retinal vessel alignment to guide targeted photocoagulation of the retinal non-perfusion (NP) areas under OCTA guidance. The specific photocoagulation method involved applying a grid pattern of spot laser (3×3) to the NP area once, with the treatment area extending beyond the NP boundary by one laser spot diameter. The total procedure duration was 10-20 minutes. | Procedure or surgery | Eyes with NPDR that were diagnosed and underwent TRP guided by OCTA at our hospital |
Primary outcome
The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months
Time frame: From enrollment to reexamination at 0,3,6,9, and 12 months
4 secondary outcomes
The number of microaneurysms, intraretinal microvascular abnormalities (IRMA) in both groups of eyes at 0, 3, 6, 9, and 12 months
Time frame: From enrollment to reexamination at 0,3,6,9, and 12 months
The number of neovascularization (NV) in both groups of eyes at 0, 3, 6, 9, and 12 months
Time frame: From enrollment to reexamination at 0,3,6,9, and 12 months
Area of foveal avascular zone (FAZ) at 0, 3, 6, 9, and 12 months in two groups of eyes
Time frame: From enrollment to reexamination at 0,3,6,9, and 12 months
DR grading at 0, 3, 6, 9, and 12 months in two groups of eyes
Time frame: From enrollment to reexamination at 0,3,6,9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. 2030, via https://pan.baidu.com
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted laser photocoagulation guided by OCTA (Optical Coherence Tomography Angiography) in people with Diabetic Retinopathy, run by Sichuan Provincial People's Hospital at 1 site in China.
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 12 inclusion and 6 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: opening soon, as of the sponsor's last update on 21 May 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, doctor (+86 139 0809 4675, lijieyk@med.uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The area size of NP (in PD units) in two groups of eyes at 0, 3, 6, 9, and 12 months (time frame: From enrollment to reexamination at 0,3,6,9, and 12 months). 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 May 2025.