Diabetic RetinopathyPhase 2IRaHiNCT01102946
Panretinal Photocoagulation (PRP) Plus Ranibizumab for Proliferative Diabetic Retinopathy
A Phase 2 study testing Ranibizumab and Panretinal Photocoagulation in people with Diabetic Retinopathy and Retinal Neovascularization, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy, Retinal Neovascularization
- What is being tested?
- Ranibizumab and Panretinal Photocoagulation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2009to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- High risk proliferative diabetic retinopathy
- Visual acuity ≥ 20/800
- No previous laser treatment for diabetic retinopathy
Who cannot join
- Previous pars plana vitrectomy
- Systemic thrombo-embolic events
- Uncontrolled systemic hypertension
- Conditions avoiding adequated documentation
- Previous eye surgery in the last 6 months before inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy
The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.
- Conditions
- Diabetic Retinopathy, Retinal Neovascularization
- Being tested
- Ranibizumab, Panretinal Photocoagulation
- Keywords
- proliferative diabetic retinopathy, retinal neovascularization, Angiogenesis Inhibitors, ranibizumab, laser
- Medical subject headings
- Diabetic Retinopathy, Retinal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Ranibizumab (Lucentis), intravitreal injections of 0.05ml
Panretinal PhotocoagulationProcedure or surgery
Panretinal photocoagulation with green laser according to ETDRS
| Study group | Role | What they receive |
|---|---|---|
| PRP plus ranibizumab | Experimental | Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab Receives: Drug: Ranibizumab; Procedure: Panretinal Photocoagulation |
| PRP | Active comparator | Patients will only be submitted to panretinal photocoagulation Receives: Procedure: Panretinal Photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescein leakage area (mm2)
Neovascularization area measured during fluorescein agiography middle phase
Measured: Week 48 after inclusion in the study
Secondary outcomes (4)
CMT
Macular thickness measured with Stratus OCT protocols
Measured: Week 48 after inclusion in the study
LogMAR BCVA
LogMAR best corrected visual acuity measured with ETDRS charts
Measured: Week 48 after inclusion in the study
Retina mid periphery visual field sensitivity change
Measured: Week 48 after inclusion in the study
Rod pathway integrity and oscillatory potential amplitudes
Measured: Week 48 after inclusion in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102946
- Sponsor's protocol ID
- IRaHi
- Acronym
- IRaHi
- Status last verified
- Jan 2011
- First submitted
- 9 Apr 2010
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Panretinal Photocoagulation Versus Panretinal Photocoagulation Plus Intravitreous Ranibizumab for High Risk Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT01102946
- Acronym / sponsor ID
- IRaHi / IRaHi
- Conditions
- Diabetic Retinopathy, Retinal Neovascularization
- Keywords
- proliferative diabetic retinopathy, retinal neovascularization, Angiogenesis Inhibitors, ranibizumab, laser
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 Apr 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.
The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP plus ranibizumab | Experimental | Drug: Ranibizumab, Procedure: Panretinal PhotocoagulationPatients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab |
| PRP | Active comparator | Procedure: Panretinal PhotocoagulationPatients will only be submitted to panretinal photocoagulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- High risk proliferative diabetic retinopathy
- Visual acuity ≥ 20/800
- No previous laser treatment for diabetic retinopathy
Key exclusion criteria (5 listed)
- Previous pars plana vitrectomy
- Systemic thrombo-embolic events
- Uncontrolled systemic hypertension
- Conditions avoiding adequated documentation
- Previous eye surgery in the last 6 months before inclusion in the 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 |
|---|---|---|
| RanibizumabAlso: LucentisRanibizumab (Lucentis), intravitreal injections of 0.05ml | Drug | PRP plus ranibizumab |
| Panretinal PhotocoagulationPanretinal photocoagulation with green laser according to ETDRS | Procedure or surgery | PRP, PRP plus ranibizumab |
Primary outcome
Fluorescein leakage area (mm2)
Time frame: Week 48 after inclusion in the study
Neovascularization area measured during fluorescein agiography middle phase
4 secondary outcomes
CMT
Time frame: Week 48 after inclusion in the study
LogMAR BCVA
Time frame: Week 48 after inclusion in the study
Retina mid periphery visual field sensitivity change
Time frame: Week 48 after inclusion in the study
Rod pathway integrity and oscillatory potential amplitudes
Time frame: Week 48 after inclusion in the study
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 4 Aug 2011.
- article on PubmedLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ranibizumab and Panretinal Photocoagulation in people with Diabetic Retinopathy and Retinal Neovascularization, run by University of Sao 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 5 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 4 Aug 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 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?
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?
Fluorescein leakage area (mm2) (time frame: Week 48 after inclusion in the study). 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 4 Aug 2011.