Avastin for PDR (Proliferative Diabetic Retinopathy)

NCT ID: NCT01270542

Last Updated: 2017-08-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-07-31

Brief Summary

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The purpose of this study is to determine the effect of anti-VEGF drug (Avastin) adminstration in eyes prior to surgical treatment for Traction retinal detachment (TRD) in patients with Proliferative Diabetic Retinopathy (PDR).

Detailed Description

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Traction retinal detachment (TRD) due to proliferative diabetic retinopathy is a blinding disease caused by contraction of fibrovascular proliferation, treatment of which is limited to surgery. Fibrosis and neovascularization are both associated with high levels of connective tissue growth factor (CTGF) and vascular endothelial growth factor (VEGF) in the eye. Small, nonrandomized studies have suggested that pre-operative adjunctive anti-VEGF administration may reduce intra- and post-operative complications and provide visual benefit in patients with this condition.

Conditions

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Retinal Detachment Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Avastin Injection Group (AIG)

Subjects in this group will get single 0.05 mL intravitreal injection of bevacizumab 1.25 mg 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.

Group Type EXPERIMENTAL

Avastin (bevacizumab)

Intervention Type DRUG

single 0.05 mL intravitreal injection of bevacizumab 1.25 mg

Sham Injection Group (SIG)

Subjects in this group will get a sham injection 3-7 days prior to surgery for tractional retinal detachment secondary to Proliferative Diabetic Retinopathy.

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type OTHER

Subject's eyes will be anesthetized but no injection will be performed.

Interventions

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Avastin (bevacizumab)

single 0.05 mL intravitreal injection of bevacizumab 1.25 mg

Intervention Type DRUG

Sham injection

Subject's eyes will be anesthetized but no injection will be performed.

Intervention Type OTHER

Other Intervention Names

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Avastin Sham

Eligibility Criteria

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Inclusion Criteria

* Active fibrovascular proliferation due to PDR with TRD given pre-operative clearance for pars plana vitrectomy (PPV) and TRD repair.

Exclusion Criteria

* Dense vitreous hemorrhage
* Inability to follow-up for surgery within 3-7 days after intravitreal injection
* History of stroke, thromboembolic event, or heart attack within the last 6 months
* Less than 18 years of age
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Southern California

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dean Eliott, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

References

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Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

Reference Type DERIVED
PMID: 37260074 (View on PubMed)

Sohn EH, He S, Kim LA, Salehi-Had H, Javaheri M, Spee C, Dustin L, Hinton DR, Eliott D. Angiofibrotic response to vascular endothelial growth factor inhibition in diabetic retinal detachment: report no. 1. Arch Ophthalmol. 2012 Sep;130(9):1127-34. doi: 10.1001/archophthalmol.2012.1611.

Reference Type DERIVED
PMID: 22965588 (View on PubMed)

Other Identifiers

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USC-HS-09-00068

Identifier Type: -

Identifier Source: org_study_id

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