NCT00370370

Brief Summary

To compare the efficacy and safety results of intravitreal bevacizumab alone with bevacizumab + triamcinolone acetonide in neovascular AMD.

Trial Health

55
Monitor

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
10 months 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
Last Updated

June 26, 2008

Status Verified

June 1, 2008

First QC Date

August 30, 2006

Last Update Submit

June 25, 2008

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Bevacizumab,TriamcinoloneAge-related macular degenerationChoroidal neovascular membrane

Outcome Measures

Primary Outcomes (1)

  • visual acuity

Secondary Outcomes (4)

  • central macular thickness

  • leakage in fluorescein angiography

  • intraocular pressure

  • anterior chamber reaction

Study Arms (2)

1

ACTIVE COMPARATOR

Injection of intravitreal bevacizumab

Drug: bevacizumab

2

ACTIVE COMPARATOR

Injection of bevacizumab + triamcinolone acetonide

Drug: bevacizumab + triamcinolone acetonide

Interventions

bevacizumabDRUG

Injection of intravitreal bevacizumab

1
bevacizumab + triamcinolone acetonideDRUG

Injection of bevacizumab + triamcinolone acetonide

2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cases of active neovascular AMD with visual acuity of 20/400- 20/40

You may not qualify if:

  • History of glaucoma or ocular hypertension
  • Disciform scar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

BevacizumabTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

November 1, 2005

Last Updated

June 26, 2008

Record last verified: 2008-06

Locations

IR(1)