Proliferative Diabetic RetinopathyNCT07315802
New Pattern of Retinal Laser Treatment for PDR
A study testing A new pattern of retinal laser in people with Proliferative Diabetic Retinopathy and Photocoagulation Burn to Retina, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Photocoagulation Burn to Retina
- What is being tested?
- A new pattern of retinal laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Jan 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having given free and informed consent to take part in the study.
- Diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);
- Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.
Who cannot join
- Previous treatment with PRP;
- Previous treatment with anti-VEGF agents or corticosteroids within 3 months;
- 2. Severe cataract, massive vitreous hemorrhage, or extensive preretinal hemorrhage that makes pan retinal photocoagulation impossible; 3. Unable to tolerate argon-laser retinal treatment.; 4. Vitreous macular traction or traction retinal detachment need to be performed with vitrectomy; 5. Retinal vascular occlusion, age-related macular degeneration, retinal angioma, uveitis, glaucoma, optic neuropathy, or other ocular diseases that can lead to vitreous hemorrhage and/or neovascularization; 6. Other conditions that the researcher found improper to be included into this study.
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
Eye and ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200030
Zhongcui Sun, PhD, +8621-64377134-2501, zhongcui.sun@aliyun.com
About this study
Official title: A Prospective Study on a New Pattern of Retinal Laser Treatment for Proliferative Diabetic Retinopathy (PDR)
The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).
Read the detailed description
Argon-laser pan retinal photocoagulation (PRP) is the first-line therapy for proliferative diabetic retinopathy (PDR) nowadays, which is believed to function by reducing retinal ischemia and decreasing the stimulation for neovascularization. However, diabetic retinopathy (DR) would still progress uncontrollably even after PRP, and PRP would result in reduction in visual acuity and loss of peripheral visual field, which may be influenced by the distribution pattern of the retinal laser treatment.
A variety of modified argon-laser patterns have been reported - a more central PRP, a more peripheral PRP, a central-sparing PRP or an extended-targeted PRP, yet the risk of developing neovascularization is higher in retina around the posterior vascular arcades and alongside the major retinal vessels.
This study will include 300 patients with PDR, who will be treated with a new pattern of argon-laser. An initial retinal laser would be given in the posterior retina outside the arcades and the mid-peripheral retina flanking the large vessels. Then investigators will conduct no less than 2 years follow-up. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress, aiming to stop DR progression with the minimum of laser energy.
- Being tested
- A new pattern of retinal laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A new pattern of retinal laserProcedure or surgery
A new pattern of retinal argon laser combines anti VEGF treatment within 2 weeks. Spot argon-laser photocoagulation was started 1 disc-diameter nasal to the optic disc, outside the superior and inferior vascular arcades, and 2 disc diameter (DD) temporal to the fovea, and the mid-peripheral retina flanking the large vessels. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress.
| Study group | Role | What they receive |
|---|---|---|
| Retinal laser | Experimental | This is a single arm study using literature-reported outcomes of PDR patients as the comparator. Receives: Procedure: A new pattern of retinal laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
BCVA stands for best-corrected visual acuity, measured by Snellen chart.
Measured: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)
CMT
CMT stands for central macular thickness, measured with optical coherence tomography (OCT) images, which serves as one of the key indicators of DR progression.
Measured: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)
Mean VF loss
VF stands for visual field. Mean deviation would be used to evaluate the VF loss.
Measured: 1 year and 2 years after the initial laser treatment during the follow-up period.
Further treatment
Number of participants with further laser treatment, anti-VEGF treatment or vitrectomy.
Measured: From enrollment to the end of the 2-year follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315802
- Sponsor's protocol ID
- Retinal Laser for PDR
- Status last verified
- Jan 2026
- First submitted
- 18 Dec 2025
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on a New Pattern of Retinal Laser Treatment for Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT07315802
- Acronym / sponsor ID
- Retinal Laser for PDR
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 2 Jan 2026 (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.
The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).
Detailed description
Argon-laser pan retinal photocoagulation (PRP) is the first-line therapy for proliferative diabetic retinopathy (PDR) nowadays, which is believed to function by reducing retinal ischemia and decreasing the stimulation for neovascularization. However, diabetic retinopathy (DR) would still progress uncontrollably even after PRP, and PRP would result in reduction in visual acuity and loss of peripheral visual field, which may be influenced by the distribution pattern of the retinal laser treatment.
A variety of modified argon-laser patterns have been reported - a more central PRP, a more peripheral PRP, a central-sparing PRP or an extended-targeted PRP, yet the risk of developing neovascularization is higher in retina around the posterior vascular arcades and alongside the major retinal vessels.
This study will include 300 patients with PDR, who will be treated with a new pattern of argon-laser. An initial retinal laser would be given in the posterior retina outside the arcades and the mid-peripheral retina flanking the large vessels. Then investigators will conduct no less than 2 years follow-up. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress, aiming to stop DR progression with the minimum of laser energy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal laser | Experimental | Procedure: A new pattern of retinal laserThis is a single arm study using literature-reported outcomes of PDR patients as the comparator. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having given free and informed consent to take part in the study.
- Diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);
- Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.
Key exclusion criteria (3 listed)
- Previous treatment with PRP;
- Previous treatment with anti-VEGF agents or corticosteroids within 3 months;
- 2. Severe cataract, massive vitreous hemorrhage, or extensive preretinal hemorrhage that makes pan retinal photocoagulation impossible; 3. Unable to tolerate argon-laser retinal treatment.; 4. Vitreous macular traction or traction retinal detachment need to be performed with vitrectomy; 5. Retinal vascular occlusion, age-related macular degeneration, retinal angioma, uveitis, glaucoma, optic neuropathy, or other ocular diseases that can lead to vitreous hemorrhage and/or neovascularization; 6. Other conditions that the researcher found improper to be included into this study.
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 |
|---|---|---|
| A new pattern of retinal laserA new pattern of retinal argon laser combines anti VEGF treatment within 2 weeks. Spot argon-laser photocoagulation was started 1 disc-diameter nasal to the optic disc, outside the superior and inferior vascular arcades, and 2 disc diameter (DD) temporal to the fovea, and the mid-peripheral retina flanking the large vessels. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress. | Procedure or surgery | Retinal laser |
Primary outcome
BCVA
Time frame: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)
BCVA stands for best-corrected visual acuity, measured by Snellen chart.
CMT
Time frame: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)
CMT stands for central macular thickness, measured with optical coherence tomography (OCT) images, which serves as one of the key indicators of DR progression.
Mean VF loss
Time frame: 1 year and 2 years after the initial laser treatment during the follow-up period.
VF stands for visual field. Mean deviation would be used to evaluate the VF loss.
Further treatment
Time frame: From enrollment to the end of the 2-year follow-up period.
Number of participants with further laser treatment, anti-VEGF treatment or vitrectomy.
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 20 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A new pattern of retinal laser in people with Proliferative Diabetic Retinopathy and Photocoagulation Burn to Retina, run by Eye & ENT Hospital of Fudan University 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 3 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: opening soon, as of the sponsor's last update on 20 Jan 2026. 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 Zhongcui Sun, PhD (+8621-64377134-2501, zhongcui.sun@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)). 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 20 Jan 2026.