Diabetes Type 1 or 2 With Diabetic RetinopathyPhase 3PascalNCT01766362
Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
A Phase 3 study testing PRPC using Pascal laser in people with Diabetes Type 1 or 2 With Diabetic Retinopathy, run by Centre Hospitalier Universitaire Dijon at 3 sites in France.
Trial summary
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1 or 2 With Diabetic Retinopathy
- What is being tested?
- PRPC using Pascal laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 3 sitesFrance
- Study dates
- Oct 2011to Nov 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Diabetes type 1 or 2
- Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
- Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
- Subjects registered with a social security agency
- Subjects who have provided written informed consent
- Subjects aged 18 or above
Who cannot join
- Pregnancy
- Breastfeeding women
- Patients presenting a contra-indication to Mydriaticum and Neosynephrine
- History of glaucoma or non-controlled ocular hypertension
- Blindness in one eye
- History of renal insufficiency requiring dialysis, or kidney or pancreas transplantation
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- Unbalanced diabetes requiring, in the previous 4 months, intensive insulin therapy.
- Central macular thickness greater than 350 µm
- Visual acuity less than 20/32 measured using an ETDRS chart
- Proliferative diabetic retinopathy associated with "high risk factors" (extensive prepapillary neovessels and/or preretinal or prepapillary neovessels associated with preretinal of intravitreal hemorrhage)
- Macular edema due to causes other than diabetic retinopathy (venous occlusion, uveitis) or occurring in a context of vitreomacular traction
- Already started PRPC
- History of eye surgery or YAG laser capsulotomy performed during the preceding 6 months
- Subjects under legal supervision or guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Dijon
Dijon, 21000
CHU de la Croix Rousse
Lyon, 69004
Hôpital Lariboisière
Paris, 75475
About this study
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.
- Being tested
- PRPC using Pascal laser
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPC using Pascal laserProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| A session | Experimental | Not described Receives: Procedure: PRPC using Pascal laser |
| Four sessions | Other | Every session are spaced out of month Receives: Procedure: PRPC using Pascal laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness
Central macular thickness at 9 months after the start of PRPC using Pascal laser.
Measured: 9 months after the start of traitement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startOct 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 1 or 2 With Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766362
- Sponsor's protocol ID
- Creuzot Innov 2010
- Acronym
- Pascal
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2013
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gabrielle PH, Massin P, Kodjikian L, Erginay A, Pallot C, Jonval L, Soudry A, Couturier A, Vardanian-Vartin C, Bron AM, Creuzot-Garcher C. Central retinal thickness following panretinal photocoagulation using a multispot semi-automated pattern-scanning laser to treat ischaemic diabetic retinopathy: Treatment in one session compared with four monthly sessions. Acta Ophthalmol. 2019 Aug;97(5):e680-e687. doi: 10.1111/aos.14002. Epub 2018 Dec 18.
PubMed 30561087
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Macular Edema After Panretinal Photocoagulation (PRPC) Performed in a Single Session Versus Four Sessions in Diabetic Patients.
- ClinicalTrials.gov ID
- NCT01766362
- Acronym / sponsor ID
- Pascal / Creuzot Innov 2010
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 11 Jan 2013 (estimated)
- 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.
The aim of this study is to show that PRPC performed in a single session using a Pascal laser leads to better management of the disease (better rate of regression of neovessels, lower risk of a loss of visual acuity in the long term related to macular edema), a saving of time and better comfort for both patient and doctor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A session | Experimental | Procedure: PRPC using Pascal laser |
| Four sessions | Other | Procedure: PRPC using Pascal laserEvery session are spaced out of month |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes type 1 or 2
- Subjects with severe non-proliferative or early proliferative diabetic retinopathy (according to the Alfediam classification)
- Subjects with central macular thickness less than or equal to 350 µm according to spetralis OCT
- Subjects registered with a social security agency
- Subjects who have provided written informed consent
Key exclusion criteria (14 listed)
- Pregnancy
- Breastfeeding women
- Patients presenting a contra-indication to Mydriaticum and Neosynephrine
- History of glaucoma or non-controlled ocular hypertension
- Blindness in one eye
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 |
|---|---|---|
| PRPC using Pascal laser | Procedure or surgery | A session, Four sessions |
Primary outcome
Macular thickness
Time frame: 9 months after the start of traitement
Central macular thickness at 9 months after the start of PRPC using Pascal laser.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 30561087Gabrielle PH, Massin P, Kodjikian L, Erginay A, Pallot C, Jonval L, Soudry A, Couturier A, Vardanian-Vartin C, Bron AM, Creuzot-Garcher C. Central retinal thickness following panretinal photocoagulation using a multispot semi-automated pattern-scanning laser to treat ischaemic diabetic retinopathy: Treatment in one session compared with four monthly sessions. Acta Ophthalmol. 2019 Aug;97(5):e680-e687. doi: 10.1111/aos.14002. Epub 2018 Dec 18.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PRPC using Pascal laser in people with Diabetes Type 1 or 2 With Diabetic Retinopathy, run by Centre Hospitalier Universitaire Dijon at 3 sites in France.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular thickness (time frame: 9 months after the start of traitement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01766362, which also lists 1 linked publication.
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 9 Feb 2026.