Retinal DetachmentPhase 2BEARRDNCT02192970
Bevacizumab Against Recurrent Retinal Detachment
A Phase 2 study testing Bevacizumab in people with Retinal Detachment and Proliferative Vitreoretinopathy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment, Proliferative Vitreoretinopathy
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2015to 11 Nov 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- Eyes with rhegmatogenous retinal detachment
Who cannot join
- Presence of PVR
- Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy.
- Recent intravitreal injection of an anti-VEGF agent less than 3 months prior
- Secondary retinal detachment repair
- Use of silicone oil as tamponade agent
- Patients less than 18 years of age
- Pregnancy
- Known allergy or contraindication to intravitreal bevacizumab
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.
- Being tested
- Bevacizumab
- Keywords
- Retinal detachment, Proliferative vitreoretinopathy
- Medical subject headings
- Retinal Detachment, Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab | Experimental | Pars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. Receives: Drug: Bevacizumab |
| Chart review | No intervention | Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
Measured: 6 months
Secondary outcomes (1)
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start21 Jan 2015
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DetachmentStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Altaweel, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192970
- Sponsor's protocol ID
- 2014-0931
- Other IDs
- A536070, SMPH/OPHTHAL&VIS SCI
- Acronym
- BEARRD
- Status last verified
- Mar 2021
- First submitted
- 15 Jul 2014
- Last updated
- 26 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Pennock S, Kim D, Mukai S, Kuhnle M, Chun DW, Matsubara J, Cui J, Ma P, Maberley D, Samad A, Van Geest RJ, Oberstein SL, Schlingemann RO, Kazlauskas A. Ranibizumab is a potential prophylaxis for proliferative vitreoretinopathy, a nonangiogenic blinding disease. Am J Pathol. 2013 May;182(5):1659-70. doi: 10.1016/j.ajpath.2013.01.052. Epub 2013 Apr 9.
PubMed 23582767
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bevacizumab Against Recurrent Retinal Detachment
- ClinicalTrials.gov ID
- NCT02192970
- Acronym / sponsor ID
- BEARRD / 2014-0931
- Keywords
- Retinal detachment, Proliferative vitreoretinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 17 Jul 2014 (estimated)
- Results
- Posted 26 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab | Experimental | Drug: BevacizumabPars plana vitrectomy will be performed in the typical manner. After laser retinopexy and prior to air-gas exchange, intravitreal bevacizumab will be administered through the trocar. Either perfluoropropane (C3F8) or sulfur hexafluoride (SF6) gas will then be administered for long-term retinal tamponade and the vitrectomy ports closed in the usual manner. |
| Chart review | No intervention | –Review records over the past 5 years of patients who underwent vitrectomy for retinal detachment repair to found out the percentage of those who had re-detachment of the retina within 6 months after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Eyes with rhegmatogenous retinal detachment
Key exclusion criteria (8 listed)
- Presence of PVR
- Need for a procedure other than primary PPV such as a scleral buckle with or without PPV, laser retinopexy, or pneumatic retinopexy.
- Recent intravitreal injection of an anti-VEGF agent less than 3 months prior
- Secondary retinal detachment repair
- Use of silicone oil as tamponade agent
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 |
|---|---|---|
| BevacizumabAlso: Avastin | Drug | Bevacizumab |
Primary outcome
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
Time frame: 6 months
Complete success of primary vitrectomy surgery, defined as retinal re-attachment without the need for any additional surgical procedures.
1 secondary outcome
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23582767Pennock S, Kim D, Mukai S, Kuhnle M, Chun DW, Matsubara J, Cui J, Ma P, Maberley D, Samad A, Van Geest RJ, Oberstein SL, Schlingemann RO, Kazlauskas A. Ranibizumab is a potential prophylaxis for proliferative vitreoretinopathy, a nonangiogenic blinding disease. Am J Pathol. 2013 May;182(5):1659-70. doi: 10.1016/j.ajpath.2013.01.052. Epub 2013 Apr 9.
- Related InfoLink provided by the sponsor.
Related trials for Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
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.
Michael Altaweel, MD principal investigator
University of Wisconsin, Madison
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 Bevacizumab in people with Retinal Detachment and Proliferative Vitreoretinopathy, run by University of Wisconsin, Madison at 1 site in United States.
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 8 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 26 Mar 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery (time frame: 6 months). 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 NCT02192970, 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 26 Mar 2021.