Clinical trial NCT01860586: Eye Injections of Bevacizumab for Lowering Risk of Scar Tissue in the Retina and Repeated Retinal Detachment.
Official title: A Prospective Pilot Study Evaluating the Effect of Intravitreal Injection of Bevacizumab on Recurrent Retinal Detachment Due to Proliferative Vitreoretinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinal Detachment
Vitreoretinopathy Proliferative
Keywords: pvr
rd
Proliferative Vitreoretinopathy
retinal detachment
detachment
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Outcomes were compared to a retrospective, historical control group.
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)
timeFrame: up to 6 months
Secondary outcomes:
measure: The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)
timeFrame: 6 months
Other outcomes:
measure: Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).
timeFrame: 6 months
Locations:
city: Philadelphia
country: United States
facility: Mid Atlantic Retina- Wills Eye Institute
state: Pennsylvania
Study officials:
affiliation: WillsEye Hospital
name: Jason Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References: