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Eye Injections of Bevacizumab for Lowering Risk of Scar Tissue in the Retina and Repeated Retinal Detachment.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Hsu, MD, Wills Eye
ClinicalTrials.gov Identifier:
NCT01860586
First received: May 20, 2013
Last updated: March 3, 2017
Last verified: March 2017
  Purpose
The purpose of this study is to examine the effects of a drug called bevacizumab (Avastin) on the rates of recurrent retinal detachment and scar tissue formation.

Condition Intervention
Retinal Detachment
Vitreoretinopathy Proliferative
Drug: Bevacizumab

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Outcomes were compared to a retrospective, historical control group.
Masking: No masking
Primary Purpose: Treatment
Official Title: A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy

Resource links provided by NLM:


Further study details as provided by Wills Eye:

Primary Outcome Measures:
  • The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease) [ Time Frame: up to 6 months ]
    This will be assessed by the frequency (occurences) of retinal detachments in patients that have intravitreal bevacizumab injections versus prior patients that did not have intravitreal bevacizumab injections.


Secondary Outcome Measures:
  • The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease) [ Time Frame: 6 months ]
    To determine if intravitreal bevacizumab injections will increase or decrease the occurences (cases) of epiretinal membranes .


Other Outcome Measures:
  • Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read). [ Time Frame: 6 months ]
    Increase or decrease in amount of letters read after intravitreal bevacizumab injections versus control patient that did not receive injections of intravitreal bevacizumab.


Enrollment: 20
Study Start Date: June 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)
Drug: Bevacizumab
Bevacizumab (1.25mg/0.05mL) will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
Other Names:
  • Avastin
  • Intrasilicone oil intravitreal injection

Detailed Description:
Proliferative vitreoretinopathy (PVR) remains the most significant obstacle to successful retinal detachment (RD) repair, accounting for up to 75% of all primary surgical failures. Characterized by the proliferation of cells on the preretinal or subretinal surface, PVR ultimately leads to contraction, foreshortening, and ultimately recurrent detachment of the retina. Several PVR risk factors have been identified, including pre-existing uveitis, large retinal tears, multiple retinal breaks, detachments involving greater than two quadrants of the retina, vitreous hemorrhage, and choroidal detachment. Given the absence of a proven medical therapy for PVR and prior studies establishing VEGF as a potential therapeutic target, further clinical evaluation is warranted. Herein, we report outcomes of a prospective, non-randomized, historical-control pilot study evaluating the effect of serial intrasilicone oil bevacizumab injections on outcomes of PVR-related RD repair.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Undergoing pars plana vitrectomy with or without scleral buckling for recurrent RD due to PVR with planned silicone oil instillation.

Exclusion Criteria:

  • Prior anti-VEGF (vascular endothelial growth factor) injections within 3 months of retinal detachment surgery.
  • Traction retinal detachment due to proliferative diabetic retinopathy.
  • Inability to flatten retina completely intraoperatively
  • Known allergy or contraindication to intravitreal bevacizumab
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860586

Locations
United States, Pennsylvania
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
Principal Investigator: Jason Hsu, MD WillsEye Hospital
  More Information

Responsible Party: Jason Hsu, MD, Investigator, Wills Eye
ClinicalTrials.gov Identifier: NCT01860586     History of Changes
Other Study ID Numbers: HsuPVR13
MARPVR2013 ( Other Identifier: Mid Atlantic Retina )
Study First Received: May 20, 2013
Results First Received: March 3, 2017
Last Updated: March 3, 2017
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Wills Eye:
pvr
rd
Proliferative Vitreoretinopathy
retinal detachment
detachment

Additional relevant MeSH terms:
Dissociative Disorders
Retinal Detachment
Vitreoretinopathy, Proliferative
Mental Disorders
Retinal Diseases
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on April 28, 2017