NCT00952614

Brief Summary

The purpose of this study is to determine whether a fluocinolone sustained drug delivery implant is effective in the treatment of central retinal vein occlusion that has caused persistent macular edema and decreased visual acuity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2002

Longer than P75 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

October 1, 2002

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

June 30, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

6.6 years

First QC Date

August 4, 2009

Results QC Date

August 6, 2013

Last Update Submit

August 1, 2014

Conditions

Central Retinal Vein Occlusion

Keywords

retinal vein occlusionsustained drug delivery implantsteroidmacular edema

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) Charts

    Outcome measure based on eyes at time points with 10-letter ETDRS score improvement

    baseline (preoperatively) to 3 years postoperatively

Secondary Outcomes (1)

  • Improvement in Macular Edema on Optical Coherence Tomography and Color Photos

    baseline (preoperatively) to 3 years postoperatively

Study Arms (1)

Retisert for Retinal Vein Occlusion

EXPERIMENTAL

0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion

Device: fluocinolone acetonide (Retisert Implant, Bausch and Lomb)

Interventions

fluocinolone acetonide (Retisert Implant, Bausch and Lomb)DEVICE

sustained release device consisting of 0.59 mg of fluocinolone acetonide

Also known as: Retisert Implant, Bausch and Lomb, Rochester, NY
Retisert for Retinal Vein Occlusion

Eligibility Criteria

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

You may qualify if:

  • Patients are eligible to receive an implant if they met all the following criteria:
  • A history of central retinal vein occlusion that had caused macular edema, based on clinical evaluation and demonstrated on fundus photography, fluorescein angiography, and optical coherence tomography (OCT)
  • Macular edema at least one disc area in size that involved the fovea
  • Males and non-pregnant females at least 18 years of age
  • Intraocular Pressure (IOP) controlled at \< 21 mmHg with no more than one topical ocular antihypertensive agent
  • Ability and willingness to comply with treatment and follow up process and to understand and sign the informed consent form.
  • Initially, patients with central retinal vein occlusion were not required to have previous therapy. However, the protocol was subsequently modified to require an intravitreal injection of triamcinolone acetonide \> 12 weeks prior to study entry, with an initial decrease in macular edema and improvement in visual acuity and subsequent decline in visual acuity accompanied by increased macular edema. This modification was added to avoid enrolling patients who might have had a long-lasting response to a single intravitreal triamcinolone acetonide injection.

You may not qualify if:

  • Patients are excluded if they have an allergy to fluocinolone acetonide or any component of the delivery system, a peripheral retinal detachment in the area of implantation, or media opacity precluding evaluation of study eye status.
  • Patents with disciform scars of the fovea or atrophic changes of the macula that in the investigator's opinion would preclude benefit from treatment are excluded from the study.
  • Female patients who were pregnant or lactating or not taking precautions to avoid pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Eye Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular Edema

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal Degeneration

Results Point of Contact

Title
Glenn J. Jaffe, MD
Organization
Duke University Medical Center
jaffe001@mc.duke.edu
919-684-4458

Study Officials

  • Glenn J Jaffe, MD

    Duke Eye Center, DUMC

    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
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

October 1, 2002

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

August 6, 2014

Results First Posted

June 30, 2014

Record last verified: 2014-08

Locations

US(1)