Clinical trial NCT06549023: Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
Official title: Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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)
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2024-08-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Central subfield retinal thickness (CRT)
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Vessel Perfusion Density (VPD)
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Vessel Length Density (VLD)
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Foveal Avascular Zone (FAZ)
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Lesion size
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Macular volume
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Venular saturation
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Arteriolar saturation
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Retinal diameter
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Venular diameter
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Retinal function
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Diabetic macular edema (DME)
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Subjective experience of pain after treatment
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Subjective overall experience of the treatment
timeFrame: Baseline and 1, 3 and 6 months after treatment
measure: Cost-effectiveness
timeFrame: Baseline and 1, 3 and 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Mölndal
country: Sweden
facility: Ögonmottagning Mölndal/SU
Study officials:
affiliation: Göteborg University
name: Marita Andersson Grönlund, M.D. Prof
role: PRINCIPAL_INVESTIGATOR
References: