NCT07315802

Brief 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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

December 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

December 18, 2025

Last Update Submit

January 16, 2026

Conditions

Proliferative Diabetic RetinopathyPhotocoagulation Burn to Retina

Outcome Measures

Primary Outcomes (4)

  • BCVA

    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

    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

    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

    Number of participants with further laser treatment, anti-VEGF treatment or vitrectomy.

    From enrollment to the end of the 2-year follow-up period.

Study Arms (1)

Retinal laser

EXPERIMENTAL

This is a single arm study using literature-reported outcomes of PDR patients as the comparator.

Procedure: A new pattern of retinal laser

Interventions

A new pattern of retinal laserPROCEDURE

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.

Retinal laser

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous treatment with PRP;
  • Previous treatment with anti-VEGF agents or corticosteroids within 3 months;
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye and ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, 200030, China

Location

Central Study Contacts

Zhongcui Sun, PhD

CONTACT

+8621-64377134-2501zhongcui.sun@aliyun.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2025

First Posted

January 2, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

CN(1)