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

NCT ID: NCT00999791

Last Updated: 2010-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diffuse Diabetic Macular Edema

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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Avastin

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Diclofenac

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

Interventions

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Bevacizumab

Intervention Type DRUG

Diclofenac

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Locations

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Ophthalmic Research Center

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Masoud Soheilian, MD

Role: CONTACT

+982122585952

Facility Contacts

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Masoud Soheilian, MD

Role: primary

+98 21 22585952

Other Identifiers

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8818

Identifier Type: -

Identifier Source: org_study_id

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