NCT01270542

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

August 17, 2017

Completed
Last Updated

August 17, 2017

Status Verified

May 1, 2014

Enrollment Period

2.1 years

First QC Date

December 1, 2010

Results QC Date

May 19, 2014

Last Update Submit

July 14, 2017

Conditions

Retinal DetachmentDiabetic Retinopathy

Keywords

Traction Retinal Detachment (PDR)Proliferative Diabetic Retinopathy (PDR)

Outcome Measures

Primary Outcomes (1)

  • The Effect of an Anti-VEGF (Vascular Endothelial Growth Factor) Agent, Bevacizumab, on Levels of Vitreous and Aqueous Growth Factor Levels (pg/mL) in Eyes With Traction Retinal Detachment Due to PDR

    Comparison of vitreous VEGF levels (pg/mL) and aqueous VEGF (pg/mL) levels in bevacizumab and control groups.

    3 months after last surgery

Secondary Outcomes (2)

  • Whether Intra- and Post-operative Complications Are Decreased in Eyes Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing Proliferative Form of Diabetic Retinopathy (PDR) Surgery.

    3 months after last surgery.

  • Improvement of Visual Outcomes in Patients Given Pre-operative Adjunctive Bevacizumab in Eyes Undergoing PDR Surgery.

    3 months from last surgery

Study Arms (2)

Avastin Injection Group (AIG)

EXPERIMENTAL

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.

Drug: Avastin (bevacizumab)

Sham Injection Group (SIG)

SHAM COMPARATOR

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

Other: Sham injection

Interventions

Avastin (bevacizumab)DRUG

single 0.05 mL intravitreal injection of bevacizumab 1.25 mg

Also known as: Avastin
Avastin Injection Group (AIG)
Sham injectionOTHER

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

Also known as: Sham
Sham Injection Group (SIG)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (2)

  • 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.

    PMID: 37260074DERIVED

  • 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.

    PMID: 22965588DERIVED

MeSH Terms

Conditions

Retinal DetachmentDiabetic Retinopathy

Interventions

Bevacizumabsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Elliott Sohn
Organization
Doheny Eye Institute/USC/University of Iowa
elliott-sohn@uiowa.edu
319-356-3185

Study Officials

  • Dean Eliott, MD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2010

First Posted

January 5, 2011

Study Start

June 1, 2009

Primary Completion

July 1, 2011

Study Completion

July 1, 2012

Last Updated

August 17, 2017

Results First Posted

August 17, 2017

Record last verified: 2014-05

Locations

US(1)