NCT06653361

Brief 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. The study aims to compare ultra-widefield fluorescein angiography-based targeted retinal photocoagulation and panretinal photocoagulation in the treatment of proliferative diabetic retinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
Last Updated

October 23, 2024

Status Verified

October 1, 2024

Enrollment Period

1.5 years

First QC Date

October 20, 2024

Last Update Submit

October 21, 2024

Conditions

Proliferative Diabetic Retinopathy - High Risk

Keywords

Diabetic retinopathyLaser photocoagulationFluorescein angiography

Outcome Measures

Primary Outcomes (4)

  • BCVA

    Best Corrected Visual Acuity

    2 months

  • CMT

    Central Macular Thickness

    2 months

  • MD

    Mean Deviation

    2 months

  • VFI

    Visual Filed Index

    2 months

Study Arms (2)

TRP

EXPERIMENTAL

Targeted Retinal Photocoagulation

Procedure: Green laser

PRP

ACTIVE COMPARATOR

Panretinal Photocoagulation

Procedure: Green laser

Interventions

Green laserPROCEDURE

Green Laser

PRPTRP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • proliferative diabetic retinopathy (PDR) with neovascularization on the disc or elsewhere in the retina

You may not qualify if:

  • Participants with a history of previous history of:
  • retinal photocoagulation
  • vitreoretinal surgery
  • tractional retinal detachment
  • epiretinal membrane
  • vitreomacular traction
  • glaucoma
  • uveitis
  • media opacities like cataract, corneal opacity, vitreous hemorrhage
  • anti-VEGF injections in last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khyber Teaching Hospital Peshawar

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2024

First Posted

October 22, 2024

Study Start

September 1, 2022

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

October 23, 2024

Record last verified: 2024-10

Locations

PA(1)