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Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema

Sponsor
Shahid Beheshti University of Medical Sciences (Other)
Overall Status
Unknown status
CT.gov ID
NCT00999791
Collaborator
(none)
1
Location
2
Arms

Study Details

Study Description

Brief Summary

Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Diffuse Macular Edema is the main cause of visual disorders in diabetic patients.

Diclofenac is a cheap drug available in most of treatment centers.in animal studies the safe dosage is identified that can be used in diffuse diabetic macular edema for treatment. in this study, we are going to compare the effect of intra vitreal injection of Diclofenac and Bevacizumab in primary treatment of diffuse diabetic macular edema.

Study Design

Study Type:
Interventional
Intervention Model:
Parallel Assignment
Primary Purpose:
Treatment
Study Start Date :
Jul 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Avastin

Drug: Bevacizumab
Active Comparator: Diclofenac

Drug: Diclofenac

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • patients with clinically significant macular edema and diffuse macular edema
    Exclusion Criteria:

    • any history of focal photocoagulation

    • any prior intra ocular injection

    • history of glaucoma with high pressure

    • history of ophthalmic surgery

    • high rish PDR

    • active PDR

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ophthalmic Research Center Tehran Iran, Islamic Republic of 166666

    Sponsors and Collaborators

    • Shahid Beheshti University of Medical Sciences

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00999791
    Other Study ID Numbers:
    • 8818
    First Posted:
    Oct 22, 2009
    Last Update Posted:
    May 4, 2010
    Last Verified:
    Oct 1, 2009
    Additional relevant MeSH terms:
    Macular Edema
    Edema
    Diclofenac
    Bevacizumab

    Study Results

    No Results Posted as of May 4, 2010