Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy

NCT06549023 | Recruiting

• 1 other identifier: SMART-PRP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Proliferative diabetic retinopathy (PDR) is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR is panretinal photocoagulation (PRP). In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The purpose of this study is to compare the safety and effectiveness of single-session and multiple-session PRP.

Conditions

Proliferative Diabetic Retinopathy; Diabetic Retinopathy; Diabetic Retinopathy Visually Threatening; Diabetic Macular Edema; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Keywords

Panretinal photocoagulation (PRP); Single-session PRP; Multiple-session PRP; Navigated laser; Navilas; Central subfield retinal thickness (CRT); Macular volume; Optical coherence tomography (OCT); Swept-source optical coherence tomography (SS-OCT); Wide-field fundus imaging; OCT-angiography; Retinal oximetry; Electroretinogram (ERG)

Outcome Measures

Primary Outcomes (15)

• Central subfield retinal thickness (CRT)

  Mean change from baseline in CRT

  Baseline and 1, 3 and 6 months after treatment

• Vessel Perfusion Density (VPD)

  Mean change from baseline in VPD

  Baseline and 1, 3 and 6 months after treatment

• Vessel Length Density (VLD)

  Mean change from baseline in VLD

  Baseline and 1, 3 and 6 months after treatment

• Foveal Avascular Zone (FAZ)

  Mean change from baseline in FAZ

  Baseline and 1, 3 and 6 months after treatment

• Lesion size

  Mean change from baseline in lesion size

  Baseline and 1, 3 and 6 months after treatment

• Macular volume

  Mean change from baseline in macular volume

  Baseline and 1, 3 and 6 months after treatment

• Venular saturation

  Mean change from baseline in venular saturation

  Baseline and 1, 3 and 6 months after treatment

• Arteriolar saturation

  Mean change from baseline in arteriolar saturation

  Baseline and 1, 3 and 6 months after treatment

• Retinal diameter

  Mean change from baseline in retinal diameter

  Baseline and 1, 3 and 6 months after treatment

• Venular diameter

  Mean change from baseline in venular diameter

  Baseline and 1, 3 and 6 months after treatment

• Retinal function

  Mean change from baseline in retinal function using full-field electroretinogram (ERG)

  Baseline and 1, 3 and 6 months after treatment

• Diabetic macular edema (DME)

  Incidence of diabetic macular edema (DME)

  Baseline and 1, 3 and 6 months after treatment

• Subjective experience of pain after treatment

  Study patients' subjective experience of pain after treatment using visual analog scale (VAS)

  Baseline and 1, 3 and 6 months after treatment

• Subjective overall experience of the treatment

  Study patients' subjective overall experience of the treatment using verbal scale (VS)

  Baseline and 1, 3 and 6 months after treatment

• Cost-effectiveness

  We intend to conduct a thorough cost-effectiveness analysis, comparing the single-session approach with the traditional multiple-session treatments. This analysis will factor in direct medical costs, including the expenses related to the laser equipment, healthcare professionals' time, and the required clinical facilities. We will also consider indirect costs such as patient travel expenses and time taken off work.

  Baseline and 1, 3 and 6 months after treatment

Study Arms (2)

Single-session panretinal PRP (SS-PRP)

ACTIVE COMPARATOR

Administration of all panretinal photocoagulation (PRP) treatment in one comprehensive session, typically delivered in a single clinical visit.

Procedure: Single-session panretinal PRP (SS-PRP)

Multiple-session panretinal PRP (MS-PRP)

ACTIVE COMPARATOR

Administration of panretinal photocoagulation (PRP) treatment over two separate visits with at least one week apart.

Procedure: Multiple-session panretinal PRP (MS-PRP)

Interventions

Single-session panretinal PRP (SS-PRP) PROCEDURE

Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit.

Single-session panretinal PRP (SS-PRP)

Multiple-session panretinal PRP (MS-PRP) PROCEDURE

Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart.

Multiple-session panretinal PRP (MS-PRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Patients with type 1 or type 2 Diabetes Mellitus with newly diagnosed Proliferative Diabetic Retinopathy, PDR.
• Visual acuity ≥ 0.1 Snellen.
• CRT of less than 300 micrometer measured by OCT without cysts in the neuroretina.
• Clear media and adequately dilated pupil for PRP.

You may not qualify if:

• Intraocular surgery within the last 4 months or planned within the next 3 months.
• Previous or current center-involved diabetic macular edema (Ci-DME).
• Previous PRP, intravitreal treatment (IVT), or macular laser treatment in study eye.
• Treatment with medications known to risk macular edema.
• Media opacity preventing adequate PRP.
• General medical condition making office laser treatment very difficult or impossible.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Ögonmottagning Mölndal/SU

Mölndal, 43130, Sweden

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marita Andersson Grönlund, M.D. Prof

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imadeddin Abu Ishkheidem, M.D.

CONTACT

+46738744867; imadeddin.abu.ishkheidem@vgregion.se

Sofia Töyrä Silfverswärd, PhD

CONTACT

+46761283085; sofia.toyra.silfversward@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated to either the single-session (SS-PRP) or multiple-sessions (MS-PRP) panretinal photocoagulation groups using a computer-generated sequence. Block randomization will be utilized to ensure balanced group sizes and comparable participant characteristics.

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: November 18, 2025

Record last verified: 2025-10

Locations

SE (1)