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

ConditionsProliferative Diabetic RetinopathyDiabetic RetinopathyDiabetic Retinopathy Visually ThreateningDiabetic Macular EdemaDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Single-session panretinal PRP (SS-PRP)

    Procedure/Surgery

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

  • Multiple-session panretinal PRP (MS-PRP)

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Single-session panretinal PRP (SS-PRP)Active comparator 1 intervention
Group B: Multiple-session panretinal PRP (MS-PRP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Central subfield retinal thickness (CRT)

Mean change from baseline in CRT

Time frame
Baseline and 1, 3 and 6 months after treatment
2

Vessel Perfusion Density (VPD)

Mean change from baseline in VPD

Time frame
Baseline and 1, 3 and 6 months after treatment
3

Vessel Length Density (VLD)

Mean change from baseline in VLD

Time frame
Baseline and 1, 3 and 6 months after treatment
4

Foveal Avascular Zone (FAZ)

Mean change from baseline in FAZ

Time frame
Baseline and 1, 3 and 6 months after treatment

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Source ClinicalTrials.gov
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