NCT00370266

Brief Summary

The purpose of this study is to determine whether intraocular injection of triamcinolone is effective in the treatment of macular edema in acute branch retinal vein occlusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2003

Longer than P75 for phase_2

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

February 1, 2003

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 17, 2008

Status Verified

June 1, 2008

Enrollment Period

4.7 years

First QC Date

August 30, 2006

Last Update Submit

June 16, 2008

Conditions

Branch Retinal Vein Occlusion

Keywords

Macular edemaBranch retinal vein occlusionIntravitreal triamcinoloneMacular thicknessRetinal neovascularization

Outcome Measures

Primary Outcomes (1)

  • Central macular thickness

Secondary Outcomes (4)

  • Visual acuity

  • Retinal neovascularization

  • Intraocular pressure

  • Cataract progression

Interventions

TriamcinoloneDRUG

Eligibility Criteria

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

You may qualify if:

  • Eyes suffering from branch retinal vein occlusion with less than 2 months duration.

You may not qualify if:

  • Monocularity,
  • Previous intraocular surgery or laser therapy
  • Glaucoma or ocular hypertension
  • Significant media opacity
  • Existence of traction on the macula
  • Visual acuity ≥20/40
  • Signs of chronicity (such as cilioretinal and/or retinal shunt vessels)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alireza Ramezani, MD

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Retinal Vein OcclusionMacular EdemaRetinal Neovascularization

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMacular DegenerationRetinal DegenerationNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Alireza Ramezani, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

February 1, 2003

Primary Completion

October 1, 2007

Study Completion

December 1, 2007

Last Updated

June 17, 2008

Record last verified: 2008-06

Locations

IR(1)