Intravitreal Bevacizumab vs. Bevacizumab Combined With Triamcinolone for Neovascular AMD

The recruitment status of this study is unknown because the information has not been verified recently.

Verified June 2008 by Shaheed Beheshti Medical University. Recruitment status was Active, not recruiting

First Received on August 30, 2006. Last Updated on June 25, 2008 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370370

Purpose

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

Condition	Intervention	Phase
Neovascular Age-Related Macular Degeneration	Drug: bevacizumab Drug: bevacizumab + triamcinolone acetonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

visual acuity

Secondary Outcome Measures:

central macular thickness
leakage in fluorescein angiography
intraocular pressure
anterior chamber reaction

Study Start Date:

November 2005

Arms	Assigned Interventions
Active Comparator: 1 Injection of intravitreal bevacizumab	Drug: bevacizumab Injection of intravitreal bevacizumab
Active Comparator: 2 Injection of bevacizumab + triamcinolone acetonide	Drug: bevacizumab + triamcinolone acetonide Injection of bevacizumab + triamcinolone acetonide

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

History of glaucoma or ocular hypertension
Disciform scar

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370370

Locations

Iran, Islamic Republic of
Hamid Ahmadieh, MD
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Hamid Ahmadieh, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00370370 History of Changes
Other Study ID Numbers:	8533
Study First Received:	August 30, 2006
Last Updated:	June 25, 2008
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Bevacizumab,
Triamcinolone
Age-related macular degeneration
Choroidal neovascular membrane

Additional relevant MeSH terms:

Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions

Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012