Diabetic RetinopathyPhase 3NCT01304225
Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser
A Phase 3 study testing Panretinal photocoagulation in people with Diabetic Retinopathy, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Panretinal photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2010to Mar 2013
- 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
- proliferative or severe nonproliferative diabetic retinopathy (type 1 or type 2)
- best corrected visual acuity of 20/50 or better
- capability to read and follow instructions
- capability to sign the consignment term
Who cannot join
- best corrected visual acuity worse than 20/50
- significant macular edema responsible for visual acuity lower than 20/50
- media opacities (includes vitreous hemorrhage in the visual axis, but not a reabsorbing inferior vitreous hemorrhage)
- previous laser treatment (PRP, focal or macular grid)
- glaucoma (confirmed or suspicious)
- other diseases of the retina and optic nerve
- previous ocular surgery in the last 6 months
- impossibility to obtain good quality images of retinography, angiography or OCT
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Federal University of São Paulo
São Paulo, São Paulo, 04023062
About this study
Official title: Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies
This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. The investigators believe that using "lower" laser parameters, the clinical response may be equivalent with less adverse effects.
- Conditions
- Diabetic Retinopathy
- Being tested
- Panretinal photocoagulation
- Keywords
- diabetic retinopathy, photocoagulation, PASCAL laser
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Panretinal photocoagulationProcedure or surgery
Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
Panretinal photocoagulationProcedure or surgery
Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
Panretinal photocoagulationProcedure or surgery
Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion
| Study group | Role | What they receive |
|---|---|---|
| 100ms single-shot | Active comparator | Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion Receives: Procedure: Panretinal photocoagulation |
| 20ms multiple-shot | Experimental | Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion Receives: Procedure: Panretinal photocoagulation |
| 20ms multiple-shot, barely visible | Experimental | Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion Receives: Procedure: Panretinal photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of severe visual loss after 1 year
Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)
Measured: 1 year
Secondary outcomes (3)
Clinical involution of retinal new vessels
Clinical involution of retinal new vessels will be evaluated with retinography and fluorescein angiography
Measured: 1 year
Nerve fiber layer thickness
Nerve fiber layer thickness will be evaluated with Spectral Domain OCT
Measured: 1 year
Retinal sensitivity
Retinal sensitivity will be evaluated with Humphrey computerized perimetry and FDT (Frequency Doubling Technology)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionMar 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304225
- Sponsor's protocol ID
- PASCAL-001
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Modi D, Chiranand P, Akduman L. Efficacy of patterned scan laser in treatment of macular edema and retinal neovascularization. Clin Ophthalmol. 2009;3:465-70. doi: 10.2147/opth.s6486. Epub 2009 Aug 20.
PubMed 19714265Muqit MM, Gray JC, Marcellino GR, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Dick AD, Stanga PE. In vivo laser-tissue interactions and healing responses from 20- vs 100-millisecond pulse Pascal photocoagulation burns. Arch Ophthalmol. 2010 Apr;128(4):448-55. doi: 10.1001/archophthalmol.2010.36.
PubMed 20385940Muqit MM, Marcellino GR, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Stanga PE. Single-session vs multiple-session pattern scanning laser panretinal photocoagulation in proliferative diabetic retinopathy: The Manchester Pascal Study. Arch Ophthalmol. 2010 May;128(5):525-33. doi: 10.1001/archophthalmol.2010.60.
PubMed 20457972Nagpal M, Marlecha S, Nagpal K. Comparison of laser photocoagulation for diabetic retinopathy using 532-nm standard laser versus multispot pattern scan laser. Retina. 2010 Mar;30(3):452-8. doi: 10.1097/IAE.0b013e3181c70127.
PubMed 20216293
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panretinal Photocoagulation for Diabetic Retinopathy With PASCAL Laser - an Anatomic and Functional Evaluation of Different Treatment Strategies
- ClinicalTrials.gov ID
- NCT01304225
- Acronym / sponsor ID
- PASCAL-001
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, photocoagulation, PASCAL laser
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 25 Feb 2011 (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.
This study will investigate the clinical efficacy and safety of the PASCAL laser (PAttern SCAn Laser) for diabetic retinopathy. Patients with proliferative or severe nonproliferative retinopathy will be treated with panretinal photocoagulation utilizing different treatment strategies. The investigators believe that using "lower" laser parameters, the clinical response may be equivalent with less adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100ms single-shot | Active comparator | Procedure: Panretinal photocoagulationPanretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion |
| 20ms multiple-shot | Experimental | Procedure: Panretinal photocoagulationPanretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion |
| 20ms multiple-shot, barely visible | Experimental | Procedure: Panretinal photocoagulationPanretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- proliferative or severe nonproliferative diabetic retinopathy (type 1 or type 2)
- best corrected visual acuity of 20/50 or better
- capability to read and follow instructions
- capability to sign the consignment term
Key exclusion criteria (8 listed)
- best corrected visual acuity worse than 20/50
- significant macular edema responsible for visual acuity lower than 20/50
- media opacities (includes vitreous hemorrhage in the visual axis, but not a reabsorbing inferior vitreous hemorrhage)
- previous laser treatment (PRP, focal or macular grid)
- glaucoma (confirmed or suspicious)
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 |
|---|---|---|
| Panretinal photocoagulationPanretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion | Procedure or surgery | 100ms single-shot |
| Panretinal photocoagulationPanretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion | Procedure or surgery | 20ms multiple-shot |
| Panretinal photocoagulationPanretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion | Procedure or surgery | 20ms multiple-shot, barely visible |
Primary outcome
Incidence of severe visual loss after 1 year
Time frame: 1 year
Severe visual loss is defined as visual acuity worse or equal to 5/200 in two consecutive visits (DRS/ETDRS primary outcome)
3 secondary outcomes
Clinical involution of retinal new vessels
Time frame: 1 year
Nerve fiber layer thickness
Time frame: 1 year
Retinal sensitivity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
- Background: PubMed 19714265Modi D, Chiranand P, Akduman L. Efficacy of patterned scan laser in treatment of macular edema and retinal neovascularization. Clin Ophthalmol. 2009;3:465-70. doi: 10.2147/opth.s6486. Epub 2009 Aug 20.
- Background: PubMed 20385940Muqit MM, Gray JC, Marcellino GR, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Dick AD, Stanga PE. In vivo laser-tissue interactions and healing responses from 20- vs 100-millisecond pulse Pascal photocoagulation burns. Arch Ophthalmol. 2010 Apr;128(4):448-55. doi: 10.1001/archophthalmol.2010.36.
- Background: PubMed 20457972Muqit MM, Marcellino GR, Henson DB, Young LB, Patton N, Charles SJ, Turner GS, Stanga PE. Single-session vs multiple-session pattern scanning laser panretinal photocoagulation in proliferative diabetic retinopathy: The Manchester Pascal Study. Arch Ophthalmol. 2010 May;128(5):525-33. doi: 10.1001/archophthalmol.2010.60.
- Background: PubMed 20216293Nagpal M, Marlecha S, Nagpal K. Comparison of laser photocoagulation for diabetic retinopathy using 532-nm standard laser versus multispot pattern scan laser. Retina. 2010 Mar;30(3):452-8. doi: 10.1097/IAE.0b013e3181c70127.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Panretinal photocoagulation in people with Diabetic Retinopathy, run by Federal University of São Paulo at 1 site in Brazil.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Feb 2011. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renato M Passos, MD (55 11 50852043, renatompassos@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of severe visual loss after 1 year (time frame: 1 year). 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 NCT01304225, which also lists 4 linked publications.
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 25 Feb 2011.