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OpenTrials
Completed

NCT Number: NCT01860586

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

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.

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Key information

Conditions

Retinal Detachment Eye Diseases Retinal Diseases Vitreoretinopathy Proliferative Vitreoretinopathy, Proliferative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

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

Primary outcomes

  1. 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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 22, 2013
Registry last updated
Apr 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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