NCT01860586

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.

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 2013

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

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed
Last Updated

April 17, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

May 20, 2013

Results QC Date

March 3, 2017

Last Update Submit

March 3, 2017

Conditions

Retinal DetachmentVitreoretinopathy Proliferative

Keywords

pvrrdProliferative Vitreoretinopathyretinal detachmentdetachment

Outcome Measures

Primary Outcomes (1)

  • The Effect of Intravitreal Bevacizumab Injections on Rate of Recurrent Retinal Detachment (Increase or Decrease)

    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.

    up to 6 months

Secondary Outcomes (1)

  • The Effect of Intravitreal Bevacizumab Injections on the Development of Epiretinal Membranes (Increase or Decrease)

    6 months

Other Outcomes (1)

  • Intravitreal Bevacizumab Injections Impact on Visual Acuity Score (Change in Letters Read).

    6 months

Study Arms (1)

Bevacizumab

EXPERIMENTAL

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

Interventions

BevacizumabDRUG

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.

Also known as: Avastin, Intrasilicone oil intravitreal injection
Bevacizumab

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid Atlantic Retina- Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Retinal DetachmentVitreoretinopathy, Proliferative

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

This pilot study has several limitations, including small sample size, its non-randomized nature, and use of historical controls for outcome comparisons.

Results Point of Contact

Title
Dr. Jason Hsu, Principal Investigator
Organization
Mid-Atlantic Retina
jshu@midatlanticretina.com
215-928-3092

Study Officials

  • Jason Hsu, MD

    WillsEye Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Outcomes were compared to a retrospective, historical control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

June 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 17, 2017

Results First Posted

April 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Locations

US(1)