Proliferative Diabetic RetinopathyPhase 1/2INIPENCT00993525
Intravitreal Ranibizumab For Persistent New Vessels In Diabetic Retinopathy(Inipe Study)
A Phase 1/2 study testing Intravitreal injection of ranibizumab in people with Proliferative Diabetic Retinopathy, run by University of Sao Paulo.
Trial summary
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy. 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?
- Intravitreal injection of ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Mar 2010
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
- logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.
Who cannot join
- history of vitrectomy in the study eye;
- history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
- major surgery within the prior 6 months or planned within the next 28 days;
- uncontrolled hypertension;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
About this study
Official title: INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.
- Conditions
- Proliferative Diabetic Retinopathy
- Being tested
- Intravitreal injection of ranibizumab
- Keywords
- diabetic retinopathy, ranibizumab, new vessels, intravitreal injection, Persistent retina new vessels
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of ranibizumabDrug
Also called Lucentis
0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal anti-VEGF | Experimental | Intravitreal injection of 0.5 mg of ranibizumab Receives: Drug: Intravitreal injection of ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
total area of fluorescein leakage from active new vessels
Measured: baseline, weeks 1,6,12,24,36,48
Best corrected Visual Acuity (BCVA)
Measured: Baseline, weeks 1,6,12,24,36,48
central macular thickness
Measured: baseline, weeks 1,6,12,24,36,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (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 Proliferative 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA), Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Rodrigo Jorge, MD, Study chair, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993525
- Sponsor's protocol ID
- 3003/2009
- Acronym
- INIPE
- Status last verified
- Oct 2009
- First submitted
- 9 Oct 2009
- Last updated
- 12 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Messias A, Ramos Filho JA, Messias K, Almeida FP, Costa RA, Scott IU, Gekeler F, Jorge R. Electroretinographic findings associated with panretinal photocoagulation (PRP) versus PRP plus intravitreal ranibizumab treatment for high-risk proliferative diabetic retinopathy. Doc Ophthalmol. 2012 Jun;124(3):225-36. doi: 10.1007/s10633-012-9322-5. Epub 2012 Mar 29.
PubMed 22457045
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTRAVITREAL RANIBIZUMAB FOR PERSISTENT NEW VESSELS IN DIABETIC RETINOPATHY (INIPE STUDY)
- ClinicalTrials.gov ID
- NCT00993525
- Acronym / sponsor ID
- INIPE / 3003/2009
- Conditions
- Proliferative Diabetic Retinopathy
- Keywords
- diabetic retinopathy, ranibizumab, new vessels, intravitreal injection, Persistent retina new vessels
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Apoio ao Ensino Pesquisa e Assitência do HCFMRPUSP (FAEPA), Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 12 Oct 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.
To evaluate the fluorescein angiographic and visual acuity effects of a single intravitreal injection of ranibizumab for the management of persistent new vessels associated with diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal anti-VEGF | Experimental | Drug: Intravitreal injection of ranibizumabIntravitreal injection of 0.5 mg of ranibizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- persistent new vessels,defined as fine retinal vessels with dilated buds or tips covered with hemorrhage or associated with recurrent vitreous hemorrhage or paucity of accompanying fibrous tissue and/or increased in extent compared to previous visit,unresponsive to complete panretinal laser photocoagulation performed at least 4 months prior;
- logarithm of minimum angle of resolution (logMAR) best-corrected visual acuity of 0.17 (Snellen equivalent, 20/30) or worse.
Key exclusion criteria (5 listed)
- history of vitrectomy in the study eye;
- history of thromboembolic event (including myocardial infarction or cerebral vascular accident);
- major surgery within the prior 6 months or planned within the next 28 days;
- uncontrolled hypertension;
- known coagulation abnormalities or current use of anticoagulative medication other than aspirin.
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 |
|---|---|---|
| Intravitreal injection of ranibizumabAlso: Lucentis0.5 mg at week 0 0.5mg at weeks 12,24,36,48 if fluorescein leakage from active vessels on angiography | Drug | Intravitreal anti-VEGF |
Primary outcome
total area of fluorescein leakage from active new vessels
Time frame: baseline, weeks 1,6,12,24,36,48
Best corrected Visual Acuity (BCVA)
Time frame: Baseline, weeks 1,6,12,24,36,48
central macular thickness
Time frame: baseline, weeks 1,6,12,24,36,48
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2009.
- Derived from this study: PubMed 22457045Messias A, Ramos Filho JA, Messias K, Almeida FP, Costa RA, Scott IU, Gekeler F, Jorge R. Electroretinographic findings associated with panretinal photocoagulation (PRP) versus PRP plus intravitreal ranibizumab treatment for high-risk proliferative diabetic retinopathy. Doc Ophthalmol. 2012 Jun;124(3):225-36. doi: 10.1007/s10633-012-9322-5. Epub 2012 Mar 29.
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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.
Rodrigo Jorge, MD study chair
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intravitreal injection of ranibizumab in people with Proliferative Diabetic Retinopathy, run by University of Sao Paulo.
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 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: status not confirmed, as of the sponsor's last update on 12 Oct 2009. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
total area of fluorescein leakage from active new vessels (time frame: baseline, weeks 1,6,12,24,36,48). The study lists 3 primary outcomes in all. 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 NCT00993525, 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 12 Oct 2009.