Proliferative Diabetic RetinopathyNCT01737957
Safety and Efficacy of Low-Fluence PRP for PDR
A study testing Low-fluence PRP with 532nm green LASER and Full-Fluence PRP with 532nm LASER in people with Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
Trial summary
To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Diabetic Retinopathy
- What is being tested?
- Low-fluence PRP with 532nm green LASER and Full-Fluence PRP with 532nm LASER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Nov 2012to Mar 2013
- Phase
- Interventional
- 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
- Type 1 or type 2 diabetics
- Proliferative diabetic retinopathy
Who cannot join
- Previous treatment with PRP
- Media opacities
- Previous treatment for macular edema (LASER or intravitreal injections)
- Recent (less than 6 months) ophthalmic surgery
- Only eyes
- Intra-retinal or sub-retinal fluid with foveal involvement
- Chronic renal failure
- History of liver or pancreatic transplant
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Asociación Para Evitar la Ceguera en México
Mexico City, Mexico City, 04030
About this study
Official title: Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)
To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Low-fluence PRP with 532nm green LASER, Full-Fluence PRP with 532nm LASER
- Keywords
- Proliferative Diabetic retinopathy, Pan-retinal photocoagulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fluence PRP with 532nm green LASERDevice
Also called PURE-POINT LASER
To administer low-fluence PRP in a single session for PDR
Full-Fluence PRP with 532nm LASERDevice
Also called PURE-POINT LASER
To administer full-fluence PRP in two sessions for PDR
| Study group | Role | What they receive |
|---|---|---|
| Low-fluence | Experimental | Low-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy Receives: Device: Low-fluence PRP with 532nm green LASER |
| Full-fluence | Active comparator | Full-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy Receives: Device: Full-Fluence PRP with 532nm LASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness change
Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)
Measured: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Secondary outcomes (1)
Adverse events
Presence or absence of adverse events
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Undefined
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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillermo Salcedo-Villanueva, MD, Principal investigator, Asociación para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737957
- Sponsor's protocol ID
- APEC-LFPRP
- Status last verified
- May 2024
- First submitted
- 23 Nov 2012
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Single-session, Low-fluence Panretinal Photocoagulation (PRP) for Proliferative Diabetic Retinopathy (PDR)
- ClinicalTrials.gov ID
- NCT01737957
- Acronym / sponsor ID
- APEC-LFPRP
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- Proliferative Diabetic retinopathy, Pan-retinal photocoagulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Nov 2012 (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.
To determine the safety and efficacy of a single session of low-fluence panretinal photocoagulation when compared to full-fluence PRP. Hypothesis: a single-session of low-fluence PRP will be safe regarding the progression of macular edema and the presence of adverse events, and will efficiently induce regression of neovascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-fluence | Experimental | Device: Low-fluence PRP with 532nm green LASERLow-fluence pan-retinal photocoagulation in a single session for proliferative diabetic retinopathy |
| Full-fluence | Active comparator | Device: Full-Fluence PRP with 532nm LASERFull-fluence pan-retinal photocoagulation for proliferative diabetic retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 1 or type 2 diabetics
- Proliferative diabetic retinopathy
Key exclusion criteria (8 listed)
- Previous treatment with PRP
- Media opacities
- Previous treatment for macular edema (LASER or intravitreal injections)
- Recent (less than 6 months) ophthalmic surgery
- Only eyes
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 |
|---|---|---|
| Low-fluence PRP with 532nm green LASERAlso: PURE-POINT LASERTo administer low-fluence PRP in a single session for PDR | Device | Low-fluence |
| Full-Fluence PRP with 532nm LASERAlso: PURE-POINT LASERTo administer full-fluence PRP in two sessions for PDR | Device | Full-fluence |
Primary outcome
Macular thickness change
Time frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks
Measurement of macular thickness changes by spectral domain optical coherence tomography (OCT)
1 secondary outcome
Adverse events
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Undefined). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
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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.
Guillermo Salcedo-Villanueva, MD principal investigator
Asociación para Evitar la Ceguera en México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-fluence PRP with 532nm green LASER and Full-Fluence PRP with 532nm LASER in people with Proliferative Diabetic Retinopathy, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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 2 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: stopped early, as of the sponsor's last update on 30 May 2024. 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 Mexico. 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?
The study was stopped early (reason given: Undefined). Results are not available in the source record.
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 change (time frame: Base-line, 1 week, 6 weeks, 12 weeks, 16 weeks). 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 30 May 2024.