ClinicalTrials.gg
CompletedNCT02192970BEARRDUpdated Mar 26, 2021Results posted

Bevacizumab Against Recurrent Retinal Detachment

A Phase 2 interventional study of Bevacizumab in Retinal Detachment and Proliferative Vitreoretinopathy, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-26.

Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
101
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Retinal Detachment
  • Proliferative Vitreoretinopathy

Keywords

  • Retinal detachment
  • Proliferative vitreoretinopathy
03

In context

Retinal Detachment

213 studies on the registry are indexed under Retinal Detachment; 28 are open to participants now.

This study's enrollment of 101 is above the median of 50 across 140 interventional studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,182 studies on the registry; 180 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 118 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥ 18 years
  • Eyes with rhegmatogenous retinal detachment

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
101 participants (actual)

Study arms

  • Experimental
    Bevacizumab

    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.

    Drug: Bevacizumab

  • No intervention
    Chart review

    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.

Interventions

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy

    Time frame: 6 months

07

Results

Posted Mar 26, 2021

Participant flow

Participant flow — Overall Study
MilestoneBevacizumabChart Review
Started101195
Completed95195
Not completed60
Withdrew: Lost to follow-up60

Outcome measures

PrimaryNumber 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.

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery
ParticipantsBevacizumabChart Review
Number of Participants (or Chart Reviews) With Complete Success of Primary Vitrectomy Surgery92169
SecondaryNumber of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy
ParticipantsBevacizumabChart Review
Number of Participants (or Chart Reviews) With Presence of Proliferative Vitreoretinopathy926

Adverse events

Collected over up to 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Bevacizumab0/101 (0%)0/101 (0%)0/101 (0%)
Chart Review———

Baseline characteristics

Age, Continuous
Age, Continuous(years)BevacizumabChart ReviewTotal
Mean61.4 (24 to 87)58.8 (27 to 88)59.7 (24 to 88)
Sex: Female, Male
Sex: Female, Male(Participants)BevacizumabChart ReviewTotal
Female346498
Male67131198
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)BevacizumabChart ReviewTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)BevacizumabChart ReviewTotal
United States101195296
08

Study locations

1 site
  • University of Wisconsin
    Madison, Wisconsin 53705, United States
09

References and documents

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 ↗

Related links

Study documents

  • Protocol and statistical analysis plan · Jul 18, 2017

Documents are hosted by the registry — open the source record to download them.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2015 to primary completion in Nov 2019, 57 months.

Results were first posted in Mar 2021, 1 year 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2014
First posted
Jul 17, 2014
StartActual
Jan 21, 2015
Primary completionActual
Nov 11, 2019
CompletionActual
Nov 11, 2019
Results first posted
Mar 26, 2021
Last update
Mar 26, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02192970
Responsible party
Sponsor
First posted
Jul 17, 2014
Start date
Jan 21, 2015
Primary completion
Nov 11, 2019
Completion
Nov 11, 2019
Results posted
Mar 26, 2021
Last update
Mar 26, 2021

Study contacts

Michael Altaweel, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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