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

Not Applicable

Recruiting

• Conditions: Diabetic Retinopathy; Proliferative Diabetic Retinopathy; Diabetes Mellitus, Type 1; Diabetic Retinopathy Visually Threatening; Diabetic Macular Edema; Diabetes Mellitus, Type 2
• Interventions: Procedure: Single-session panretinal PRP (SS-PRP); Procedure: Multiple-session panretinal PRP (MS-PRP)

• Registration Number: NCT06549023
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Proliferative diabetic retinopathy (PDR) is a well-known complication for both type 1 and type 2 diabetes mellitus (DM) and it is the leading cause for blindness in working-age adults. The current gold standard treatment for PDR, established more than four decades ago by the Diabetic Retinopathy Study (DRS), is panretinal photocoagulation (PRP). The treatment goal is to halt the progression of PDR by destroying parts of the peripheral retina in a pattern fashion and hence preserving the visually important central macular region. The tissue destruction reduces the area of ischemia and reduces the production of vascular endothelial growth factor (VEGF), which drives the formation of neovascular proliferations. In the management of PDR, panretinal photocoagulation (PRP) stands as a cornerstone treatment. In current clinical practice, both single-session and multiple-session PRP approaches are widely accepted and utilized. The choice between these approaches often depends on the practitioner's preference, patient characteristics, and specific clinical circumstances.

Although both single-session and multiple-session PRP are employed in practice, there's an ongoing debate regarding their comparative safety and effectiveness. Older studies suggest a heightened risk of diabetic macular edema (DME) with single-session PRP, while newer research, particularly those involving milder laser techniques, indicates that the risk might be similar regardless of the number of sessions. This inconsistency in findings underscores the need for further research and the investigators aim to shed light over this with this prospective, controlled and randomized interventional study.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-08-08
• Study First Posted: 2024-08-12
• Study Start: 2025-01-01
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-06
• Primary Completion: 2028-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-session panretinal PRP (SS-PRP)	Single-session panretinal PRP (SS-PRP)	Administration of all panretinal photocoagulation (PRP) treatment in one comprehensive session, typically delivered in a single clinical visit.
Multiple-session panretinal PRP (MS-PRP)	Multiple-session panretinal PRP (MS-PRP)	Administration of panretinal photocoagulation (PRP) treatment over two separate visits with at least one week apart.

Primary Outcome Measures

Name	Time	Method
Retinal diameter	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in retinal diameter
Venular diameter	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in venular diameter
Central subfield retinal thickness (CRT)	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in CRT
Venular saturation	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in venular saturation
Vessel Length Density (VLD)	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in VLD
Lesion size	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in lesion size
Subjective overall experience of the treatment	Baseline and 1, 3 and 6 months after treatment	Study patients' subjective overall experience of the treatment using verbal scale (VS)
Vessel Perfusion Density (VPD)	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in VPD
Foveal Avascular Zone (FAZ)	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in FAZ
Macular volume	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in macular volume
Subjective experience of pain after treatment	Baseline and 1, 3 and 6 months after treatment	Study patients' subjective experience of pain after treatment using visual analog scale (VAS)
Arteriolar saturation	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in arteriolar saturation
Retinal function	Baseline and 1, 3 and 6 months after treatment	Mean change from baseline in retinal function using full-field electroretinogram (ERG)
Diabetic macular edema (DME)	Baseline and 1, 3 and 6 months after treatment	Incidence of diabetic macular edema (DME)
Cost-effectiveness	Baseline and 1, 3 and 6 months after treatment	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.

Trial Locations

Locations (1)

Ögonmottagning Mölndal/SU; 🇸🇪 Mölndal, Sweden