Diabetic RetinopathyPhase 2RANITRANCT01201161
Ranibizumab for Diabetic Traction Retinal Detachment
A Phase 2 study testing Ranibizumab in people with Diabetic Retinopathy and Retinal Detachment, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy, Retinal Detachment
- What is being tested?
- Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2008to Jan 2010
- 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
- Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Who cannot join
- Massive vitreous hemorrhage preventing from detailed posterior pole examination;
- Previous intra-ocular surgery other than cataract surgery
- Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
- Prothrombin time, partial thromboplastin time or platelet count without normal limits
- History of previous thromboembolic events
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment
The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.
- Conditions
- Diabetic Retinopathy, Retinal Detachment
- Being tested
- Ranibizumab, Sham injection
- Keywords
- Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Preoperative Ranibizumab, pars plana vitrectomy
- Medical subject headings
- Diabetic Retinopathy, Retinal Detachment, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy
Sham injectionOther
Simulation of intravitreal injection one week before pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| RANI/PPV | Experimental | Preoperative intravitreal ranibizumab and pars plana vitrectomy Receives: Drug: Ranibizumab |
| PPV | Placebo comparator | Sham injection and pars plana vitrectomy Receives: Other: Sham injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of intraoperative intra-ocular bleeding
amount of intra-ocular bleeding that occurred during pars plana vitrectomy
Measured: one week
Secondary outcomes (1)
visual acuity
ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startDec 2008
- Primary completionJan 2010
- Study completionJan 2010
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Rodrigo Jorge, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201161
- Sponsor's protocol ID
- RANITRA
- Acronym
- RANITRA
- Status last verified
- Jan 2010
- First submitted
- 13 Sep 2010
- Last updated
- 14 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravitreous Ranibizumab on Intra-Operative Bleeding During Pars Plana Vitrectomy for Diabetic Traction Retinal Detachment
- ClinicalTrials.gov ID
- NCT01201161
- Acronym / sponsor ID
- RANITRA / RANITRA
- Conditions
- Diabetic Retinopathy, Retinal Detachment
- Keywords
- Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Preoperative Ranibizumab, pars plana vitrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Sep 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 was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RANI/PPV | Experimental | Drug: RanibizumabPreoperative intravitreal ranibizumab and pars plana vitrectomy |
| PPV | Placebo comparator | Other: Sham injectionSham injection and pars plana vitrectomy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Key exclusion criteria (5 listed)
- Massive vitreous hemorrhage preventing from detailed posterior pole examination;
- Previous intra-ocular surgery other than cataract surgery
- Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
- Prothrombin time, partial thromboplastin time or platelet count without normal limits
- History of previous thromboembolic events
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: LucentisIntravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy | Drug | RANI/PPV |
| Sham injectionSimulation of intravitreal injection one week before pars plana vitrectomy | Other | PPV |
Primary outcome
amount of intraoperative intra-ocular bleeding
Time frame: one week
amount of intra-ocular bleeding that occurred during pars plana vitrectomy
1 secondary outcome
visual acuity
Time frame: 12 weeks
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 14 Sep 2010.
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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, PhD principal investigator
University of Sao Paulo
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 in people with Diabetic Retinopathy and Retinal Detachment, 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 1 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 14 Sep 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 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. Some participants in this study may receive a placebo. 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?
amount of intraoperative intra-ocular bleeding (time frame: one week). 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 14 Sep 2010.