New Pattern of Retinal Laser Treatment for PDR

January 16, 2026 updated by: Eye & ENT Hospital of Fudan University

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200030
        • Eye and ENT Hospital of Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Having given free and informed consent to take part in the study.
  2. 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.);
  3. Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.

Exclusion Criteria:

  1. Previous treatment with PRP;
  2. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retinal laser
This is a single arm study using literature-reported outcomes of PDR patients as the comparator.
Procedure: A new pattern of retinal laser
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
1 year and 2 years after the initial laser treatment during the follow-up period.
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.
From enrollment to the end of the 2-year follow-up period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

December 18, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • Retinal Laser for PDR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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