- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00999791
Intravitreal Diclofenac Versus Avastin as Primary Treatment of Diffuse Diabetic Macular Edema
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Masoud Soheilian, MD
- Phone Number: +982122585952
- Email: labbafi@hotmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of, 166666
- Recruiting
- Ophthalmic Research Center
-
Contact:
- Masoud Soheilian, MD
- Phone Number: +98 21 22585952
- Email: labbafi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Interventional Model: Parallel Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Avastin
|
|
Active Comparator: Diclofenac
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Macular Degeneration
- Macular Edema
- Edema
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Diclofenac
Other Study ID Numbers
- 8818 (Other Identifier: CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diffuse Diabetic Macular Edema
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Asociación para Evitar la Ceguera en MéxicoUnknown
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Asociación para Evitar la Ceguera en MéxicoUnknown
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Military Institute of Medicine, PolandUnknown
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iCo Therapeutics Inc.CompletedDiffuse Diabetic Macular EdemaUnited States
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