NCT02192970

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

January 21, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 26, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

4.8 years

First QC Date

July 15, 2014

Results QC Date

March 1, 2021

Last Update Submit

March 1, 2021

Conditions

Retinal DetachmentProliferative Vitreoretinopathy

Keywords

Retinal detachmentProliferative vitreoretinopathy

Outcome Measures

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.

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

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.

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.

Interventions

BevacizumabDRUG
Also known as: Avastin
Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Eyes with rhegmatogenous retinal detachment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Related Publications (1)

  • 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.

    PMID: 23582767BACKGROUND

Related Links

MeSH Terms

Conditions

Retinal DetachmentVitreoretinopathy, Proliferative

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Michael M Altaweel, MD
Organization
University of Wisconsin - Madison
mmaltaweel@wisc.edu
(608) 263-7290

Study Officials

  • Michael Altaweel, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2014

First Posted

July 17, 2014

Study Start

January 21, 2015

Primary Completion

November 11, 2019

Study Completion

November 11, 2019

Last Updated

March 26, 2021

Results First Posted

March 26, 2021

Record last verified: 2021-03

Locations

US(1)