NCT01284478

Brief Summary

The purpose of the study is to determine where a sustained steroid delivery system (Ozurdex,Allergan) is safe and effective to treat Cystoid Macular Edema in diabetic patients after Cataract Surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 4, 2012

Status Verified

October 1, 2012

Enrollment Period

1.8 years

First QC Date

January 25, 2011

Last Update Submit

October 3, 2012

Conditions

Pseudophakic Cystoid Macular Edema,Diabetic Macular Edema

Keywords

pseudophakic cystoid macular edema, diabetic macular edema, Irvine Gass Syndrome, cataract surgery, ozurdex, dexamethasone

Outcome Measures

Primary Outcomes (1)

  • BEST CORRECTED VISUAL ACUITY (ETDRS)

    AT DAY 180

Secondary Outcomes (1)

  • RETINAL THICKNESS MEASURED BY SPECTRAL DOMAIN OPTICAL TOMOGRAPHY

    90 and 180 DAYS

Study Arms (1)

Dexamethasone Implant

OTHER

Patients will be treated with the Ozurdex (Dexamethasone Implant)

Drug: Dexamethasone Implant

Interventions

Dexamethasone ImplantDRUG

Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally

Dexamethasone Implant

Eligibility Criteria

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

You may qualify if:

  • DIABETIC PATIENTS WHO DEVELOP CYSTOID MACULA EDEMA AFTER CATARACT SURGERY (WITHIN 4-10 WEEKS AFTER SURGERY
  • VISUAL ACUITY WORSE THAN 20/32

You may not qualify if:

  • VISUAL ACUITY WORSE THAN 20/200
  • MODERATE OR SEVERE GLAUCOMA (AS DEFINED AS USING \>2 TOPICAL GLAUCOMA MEDIATIONS.
  • USE OF SYSTEMIC, PERIOCULAR OR INTRAOCULAR CORTICOSTEROIDS WITHIN 30 DAYS OF ENROLLMENT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern California Retina Vitreous Associates

Mountain View, California, 94040, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Rahul Khurana, MD

    Northern California Retina Vitreous Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 27, 2011

Study Start

January 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 4, 2012

Record last verified: 2012-10

Locations

US(1)