NCT00371111

Brief Summary

Cystoid macular edema (CME) is one of the common causes of vision loss in patients with UveitiS .Triamcinolone has been effectively used in reducing CME and improving the vision. Also there are some documents which recommend Bevacizumab(avastin) could reduce macular edema. This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2006

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 30, 2008

Status Verified

July 1, 2008

Enrollment Period

1.8 years

First QC Date

August 31, 2006

Last Update Submit

July 28, 2008

Conditions

Resistant Cystoid Macular Edema

Keywords

Resistant uveitic cystoid macular edemaintravitreal triamcinoloneintravitreal bevacizumab

Outcome Measures

Primary Outcomes (2)

  • Resorbed CME in OCT

    every 3 month

  • Resorbed CME in clinical examination

    Every 3 month

Secondary Outcomes (1)

  • need to retreatment

    when ever needed

Study Arms (2)

1

ACTIVE COMPARATOR

Intravitreal injection of Triamcinolone

Drug: Intravitreal injection of Triamcinolone

2

ACTIVE COMPARATOR

Intravitreal injection of Avastin

Drug: Intravitreal injection of Avastin

Interventions

Intravitreal injection of TriamcinoloneDRUG

4 mg of Triamcinolone

1
Intravitreal injection of AvastinDRUG

Injection of 1.25 mg of Avastin and

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uveitic CME
  • Uveitic CME refractory to routine treatment
  • Vision better than 5/200 and worse than 20/50

You may not qualify if:

  • Mono- Ocular patients
  • History of vitrectomy
  • Glaucoma or ocular hypertension
  • History of other retinal disease that can cause macular edema
  • Pregnancy
  • Significant media opacity
  • Vision better than 20/50

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masoud Soheilian , MD

Tehran, Tehran Province, 16666, Iran

Location

Study Officials

  • Masoud Soheilian, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2006

First Posted

September 1, 2006

Study Start

August 1, 2006

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

July 30, 2008

Record last verified: 2008-07

Locations

IR(1)