To Compare Therapeutic Effect of Intravitreal Bevacizumab and Triamcinolone in Resistant Uveitic Cystoid Macular Edema

• Sponsor: Shahid Beheshti University of Medical Sciences (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00371111
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 25
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Resistant Cystoid Macular Edema	Drug: Intravitreal injection of Triamcinolone; Drug: Intravitreal injection of Avastin	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: May 1, 2008
• Anticipated Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Intravitreal injection of Triamcinolone	Drug: Intravitreal injection of Triamcinolone; 4 mg of Triamcinolone
Active Comparator: 2 Intravitreal injection of Avastin	Drug: Intravitreal injection of Avastin; Injection of 1.25 mg of Avastin and

Outcome Measures

Primary Outcome Measures

1. Resorbed CME in OCT [every 3 month]

2. Resorbed CME in clinical examination [Every 3 month]

Secondary Outcome Measures

1. need to retreatment [when ever needed]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Masoud Soheilian , MD	Tehran		Iran, Islamic Republic of	16666

Sponsors and Collaborators

• Shahid Beheshti University of Medical Sciences

Investigators

• Principal Investigator: Masoud Soheilian, MD, Ophthalmic Research Center of Shaheed Beheshti Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00371111
• Other Study ID Numbers: 8524
• First Posted: Sep 1, 2006
• Last Update Posted: Jul 30, 2008
• Last Verified: Jul 1, 2008

• Keywords provided by , ,: Resistant uveitic cystoid macular edema; intravitreal triamcinolone; intravitreal bevacizumab
• Additional relevant MeSH terms: Macular Edema; Edema; Triamcinolone; Bevacizumab

Study Results

No Results Posted as of Jul 30, 2008