Proiriftrative Diabetic RetinopathyPhase 2PDRNCT01232179
Comparison of Two Laser Therapy Methods for PDR
A Phase 2 study testing conventional prp and targeted prp in people with Proiriftrative Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Proiriftrative Diabetic Retinopathy
- What is being tested?
- conventional prp and targeted prp
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Oct 2010to May 2011
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with PDR condidate for photocoagulation teraphy
- Pupil with dilatasion≥6mm
- without privious treatment with anti VEGF drugs 3months before study
- without privious vitroretinal sugery
- without privoius lasertraphy
Who cannot join
- To have NVI cricteria with increase of inraocular pressure
- to have cataract or vitrus leakage which prevent lasertraphy
- pupil smaller that 6mm
- traditional retinal detachment
- privious treatment with anti VEGF drugs 3months before study
- privious PRP
- patient unable to get wide field FAG
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Labbafinejad medical center
Tehran, Tehran Province
Masoud Soheilian, proffesor, 00982122585952, masoud_soheilian@yahoo.com
masoud soheilian, proffesor
About this study
Official title: Comparison Between Result and Side Effects of Treatment of Prolifrative Diabetic Retinopaty by Conventional and Extended Targeted Pan Retinal Photocoagolation
Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. However , the treatment may also resulting adverse effects such as blurring of central vision, visual field constriction and disturbance in dark adaptation and contrast vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause regression of the neovascularization while minimizing some of the risks and complication associated of treatment of PDR with these two methods.
- Conditions
- Proiriftrative Diabetic Retinopathy
- Being tested
- conventional prp, targeted prp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional prpProcedure or surgery
pan retinal photocoagulation
targeted prpProcedure or surgery
1200-1600 spot in far periphery retin, anterior equator
| Study group | Role | What they receive |
|---|---|---|
| conventional prp | Active comparator | Not described Receives: Procedure: conventional prp |
| targeted PRP | Active comparator | Not described Receives: Procedure: targeted prp |
What is being measured
The primary outcome is the main question the study is designed to answer.
no leakage in widefield fluorescin angiography
Measured: 3 months after lasertraphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2011 (estimated)
- Study completionMay 2011 (estimated)
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 Proiriftrative 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Investigator
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232179
- Sponsor's protocol ID
- 88100
- Acronym
- PDR
- Status last verified
- Oct 2010
- First submitted
- 1 Nov 2010
- Last updated
- 2 Nov 2010
- Results posted
- No
Publications
Nikkhah H, Ghazi H, Razzaghi MR, Karimi S, Ramezani A, Soheilian M. Extended targeted retinal photocoagulation versus conventional pan-retinal photocoagulation for proliferative diabetic retinopathy in a randomized clinical trial. Int Ophthalmol. 2018 Feb;38(1):313-321. doi: 10.1007/s10792-017-0469-7. Epub 2017 Feb 6.
PubMed 28168567
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Result and Side Effects of Treatment of Prolifrative Diabetic Retinopaty by Conventional and Extended Targeted Pan Retinal Photocoagolation
- ClinicalTrials.gov ID
- NCT01232179
- Acronym / sponsor ID
- PDR / 88100
- Conditions
- Proiriftrative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- May 2011 (estimated)
- First posted
- 2 Nov 2010 (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.
Proliferative diabetic retinopathy (PDR) is treated with conventional pan retinal photocoagulation (PRP) which can improve the visual prognosis in this complication significantly. However , the treatment may also resulting adverse effects such as blurring of central vision, visual field constriction and disturbance in dark adaptation and contrast vision. Extended targeted retinal coagulation (TRP) to the ischemic areas may cause regression of the neovascularization while minimizing some of the risks and complication associated of treatment of PDR with these two methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional prp | Active comparator | Procedure: conventional prp |
| targeted PRP | Active comparator | Procedure: targeted prp |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- patients with PDR condidate for photocoagulation teraphy
- Pupil with dilatasion≥6mm
- without privious treatment with anti VEGF drugs 3months before study
- without privious vitroretinal sugery
- without privoius lasertraphy
Key exclusion criteria (7 listed)
- To have NVI cricteria with increase of inraocular pressure
- to have cataract or vitrus leakage which prevent lasertraphy
- pupil smaller that 6mm
- traditional retinal detachment
- privious treatment with anti VEGF drugs 3months before study
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 |
|---|---|---|
| conventional prppan retinal photocoagulation | Procedure or surgery | conventional prp |
| targeted prp1200-1600 spot in far periphery retin, anterior equator | Procedure or surgery | targeted PRP |
Primary outcome
no leakage in widefield fluorescin angiography
Time frame: 3 months after lasertraphy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2010.
- Derived from this study: PubMed 28168567Nikkhah H, Ghazi H, Razzaghi MR, Karimi S, Ramezani A, Soheilian M. Extended targeted retinal photocoagulation versus conventional pan-retinal photocoagulation for proliferative diabetic retinopathy in a randomized clinical trial. Int Ophthalmol. 2018 Feb;38(1):313-321. doi: 10.1007/s10792-017-0469-7. Epub 2017 Feb 6.
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 2 study testing conventional prp and targeted prp in people with Proiriftrative Diabetic Retinopathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 7 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 2 Nov 2010. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
no leakage in widefield fluorescin angiography (time frame: 3 months after lasertraphy). 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 NCT01232179, 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 2 Nov 2010.