Proliferative Diabetic RetinopathySMART-PRPNCT06549023
Single Session vs Multiple-Session Panretinal Photocoagulation for Treatment of Proliferative Diabetic Retinopathy
A study testing Single-session panretinal PRP (SS-PRP) and Multiple-session panretinal PRP (MS-PRP) in people with Proliferative Diabetic Retinopathy and Diabetic Retinopathy, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabetic Retinopathy Visually Threatening
- What is being tested?
- Single-session panretinal PRP (SS-PRP) and Multiple-session panretinal PRP (MS-PRP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Ögonmottagning Mölndal/SU
Mölndal, 43130
Imadeddin Abu Ishkheidem, M.D., +46738744867, imadeddin.abu.ishkheidem@vgregion.se
Sofia Töyrä Silfverswärd, PhD, MSc, +46705527103, sofia.toyra.silfversward@vgregion.se
About this study
Official title: Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
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.
Read the 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.
- Conditions
- Proliferative Diabetic Retinopathy, Diabetic Retinopathy, Diabetic Retinopathy Visually Threatening, Diabetic Macular Edema, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- Being tested
- Single-session panretinal PRP (SS-PRP), Multiple-session panretinal PRP (MS-PRP)
- 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)
- Medical subject headings
- Diabetic Retinopathy, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-session panretinal PRP (SS-PRP)Procedure or 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 or surgery
Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Multiple-session panretinal PRP (MS-PRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central subfield retinal thickness (CRT)
Mean change from baseline in CRT
Measured: Baseline and 1, 3 and 6 months after treatment
Vessel Perfusion Density (VPD)
Mean change from baseline in VPD
Measured: Baseline and 1, 3 and 6 months after treatment
Vessel Length Density (VLD)
Mean change from baseline in VLD
Measured: Baseline and 1, 3 and 6 months after treatment
Foveal Avascular Zone (FAZ)
Mean change from baseline in FAZ
Measured: Baseline and 1, 3 and 6 months after treatment
Lesion size
Mean change from baseline in lesion size
Measured: Baseline and 1, 3 and 6 months after treatment
Macular volume
Mean change from baseline in macular volume
Measured: Baseline and 1, 3 and 6 months after treatment
Venular saturation
Mean change from baseline in venular saturation
Measured: Baseline and 1, 3 and 6 months after treatment
Arteriolar saturation
Mean change from baseline in arteriolar saturation
Measured: Baseline and 1, 3 and 6 months after treatment
Retinal diameter
Mean change from baseline in retinal diameter
Measured: Baseline and 1, 3 and 6 months after treatment
Venular diameter
Mean change from baseline in venular diameter
Measured: Baseline and 1, 3 and 6 months after treatment
Retinal function
Mean change from baseline in retinal function using full-field electroretinogram (ERG)
Measured: Baseline and 1, 3 and 6 months after treatment
Diabetic macular edema (DME)
Incidence of diabetic macular edema (DME)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: Baseline and 1, 3 and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Marita Andersson Grönlund, M.D. Prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549023
- Sponsor's protocol ID
- SMART-PRP
- Acronym
- SMART-PRP
- Status last verified
- Oct 2025
- First submitted
- 8 Aug 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Session vs Multiple-Session Panretinal Photocoagulation With Navigated Laser in Proliferative Diabetic Retinopathy - The SMART-PRP Study
- ClinicalTrials.gov ID
- NCT06549023
- Acronym / sponsor ID
- SMART-PRP / SMART-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)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single-session panretinal PRP (SS-PRP) | Active comparator | Procedure: 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) | Active comparator | Procedure: Multiple-session panretinal PRP (MS-PRP)Administration of panretinal photocoagulation (PRP) treatment over two separate visits with at least one week apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single-session panretinal PRP (SS-PRP)Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas in one comprehensive session, typically delivered in a single clinical visit. | Procedure or surgery | Single-session panretinal PRP (SS-PRP) |
| Multiple-session panretinal PRP (MS-PRP)Administration of panretinal photocoagulation (PRP) treatment with navigated laser using Navilas over two separate visits with at least one week apart. | Procedure or surgery | Multiple-session panretinal PRP (MS-PRP) |
Primary outcome
Central subfield retinal thickness (CRT)
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in CRT
Vessel Perfusion Density (VPD)
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in VPD
Vessel Length Density (VLD)
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in VLD
Foveal Avascular Zone (FAZ)
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in FAZ
Lesion size
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in lesion size
Macular volume
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in macular volume
Venular saturation
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in venular saturation
Arteriolar saturation
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in arteriolar saturation
Retinal diameter
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in retinal diameter
Venular diameter
Time frame: Baseline and 1, 3 and 6 months after treatment
Mean change from baseline in venular diameter
Retinal function
Time frame: 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)
Time frame: Baseline and 1, 3 and 6 months after treatment
Incidence of diabetic macular edema (DME)
Subjective experience of pain after treatment
Time frame: Baseline and 1, 3 and 6 months after treatment
Study patients' subjective experience of pain after treatment using visual analog scale (VAS)
Subjective overall experience of the treatment
Time frame: Baseline and 1, 3 and 6 months after treatment
Study patients' subjective overall experience of the treatment using verbal scale (VS)
Cost-effectiveness
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marita Andersson Grönlund, M.D. Prof principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-session panretinal PRP (SS-PRP) and Multiple-session panretinal PRP (MS-PRP) in people with Proliferative Diabetic Retinopathy and Diabetic Retinopathy, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imadeddin Abu Ishkheidem, M.D. (+46738744867, imadeddin.abu.ishkheidem@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central subfield retinal thickness (CRT) (time frame: Baseline and 1, 3 and 6 months after treatment). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.