NeovascularPFCNCT01023698
Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters
A study testing laser photocoagulation in people with Neovascular, run by Asociación para Evitar la Ceguera en México.
Trial summary
Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters? Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neovascular
- What is being tested?
- laser photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Apr 2010
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- untreated Proliferative diabetic retinopathy
Who cannot join
- Previous photocoagulation
About this study
Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?
- Conditions
- Neovascular
- Being tested
- laser photocoagulation
- Keywords
- Diabetic retinopathy, Diabetic macular edema, Panretinal photocoagulation
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser photocoagulationProcedure or surgery
Laser photocoagulation
| Study group | Role | What they receive |
|---|---|---|
| photocoagulation | Experimental | Laser photocoagulation Receives: Procedure: laser photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stabilization of proliferative diabetic retinopathy
Measured: 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionApr 2010
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 NeovascularStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria A Martinez-Castellanos, MD, Principal investigator, Asociacion para Evitar la Ceguera en México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01023698
- Sponsor's protocol ID
- APEC0003
- Acronym
- PFC
- Status last verified
- May 2024
- First submitted
- 26 Nov 2009
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
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
- Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters
- ClinicalTrials.gov ID
- NCT01023698
- Acronym / sponsor ID
- PFC / APEC0003
- Conditions
- Neovascular
- Keywords
- Diabetic retinopathy, Diabetic macular edema, Panretinal photocoagulation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Undefined
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- Apr 2009 (actual)
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Dec 2009 (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.
Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| photocoagulation | Experimental | Procedure: laser photocoagulationLaser photocoagulation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- untreated Proliferative diabetic retinopathy
Key exclusion criteria (1 listed)
- Previous photocoagulation
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 |
|---|---|---|
| laser photocoagulationLaser photocoagulation | Procedure or surgery | photocoagulation |
Primary outcome
Stabilization of proliferative diabetic retinopathy
Time frame: 2010
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.
Maria A Martinez-Castellanos, MD principal investigator
Asociacion para Evitar la Ceguera en México
Questions about this trial
What is this clinical trial studying?
A study testing laser photocoagulation in people with Neovascular, run by Asociación para Evitar la Ceguera en México.
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 1 inclusion and 1 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.
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?
Stabilization of proliferative diabetic retinopathy (time frame: 2010). 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.