To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema - Full Text View

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00371111

Purpose

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.

Condition	Intervention	Phase
Resistant Cystoid Macular Edema	Drug: Intravitreal injection of Triamcinolone Drug: Intravitreal injection of Avastin	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

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:

Resorbed CME in OCT [ Time Frame: every 3 month ] [ Designated as safety issue: No ]
Resorbed CME in clinical examination [ Time Frame: Every 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

need to retreatment [ Time Frame: when ever needed ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Intravitreal injection of Triamcinolone	Drug: Intravitreal injection of Triamcinolone 4 mg of Triamcinolone
2: Active Comparator Intravitreal injection of Avastin	Drug: Intravitreal injection of Avastin Injection of 1.25 mg of Avastin and

Detailed Description:

This study compare intravitreous injection of triamcinolone and avastin in patients with resistant uveitic cystoid macular edema.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00371111

Locations

Iran, Islamic Republic of
Masoud Soheilian , MD
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Masoud Soheilian, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided

Study ID Numbers:	8524
Study First Received:	August 31, 2006
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00371111 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Resistant uveitic cystoid macular edema
intravitreal triamcinolone
intravitreal bevacizumab

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Edema
Bevacizumab
Hormones
Triamcinolone hexacetonide
Signs and Symptoms
Macular Edema
Triamcinolone Acetonide
Therapeutic Uses

Triamcinolone
Growth Inhibitors
Angiogenesis Modulating Agents
Retinal Diseases
Growth Substances
Eye Diseases
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010