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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00999791
Other study ID # 8818
Secondary ID
Status Recruiting
Phase Phase 1
First received July 7, 2009
Last updated May 3, 2010
Start date July 2009

Study information

Verified date October 2009
Source hahid Beheshti University of Medical Sciences
Contact Masoud Soheilian, MD
Phone +982122585952
Email labbafi@hotmail.com
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bevacizumab

Diclofenac


Locations

Country Name City State
Iran, Islamic Republic of Ophthalmic Research Center Tehran

Sponsors (1)

Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

See also
  Status Clinical Trial Phase
Terminated NCT00571142 - Vitrectomy and Bevacizumab for Diffuse Diabetic Macular Edema Phase 3
Withdrawn NCT00567372 - POSTERIOR SUB-TENON'S Avastin Phase 4
Withdrawn NCT00600301 - Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study Phase 3
Completed NCT00886808 - Safety Study of iCo-007 Intravitreal Injection to Treat Diabetic Macular Edema Phase 1
Recruiting NCT01218750 - Triple Therapy for Diffuse Diabetic Macular Edema N/A