NCT00999791

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
Last Updated

May 4, 2010

Status Verified

October 1, 2009

First QC Date

July 7, 2009

Last Update Submit

May 3, 2010

Conditions

Diffuse Diabetic Macular Edema

Study Arms (2)

Avastin

ACTIVE COMPARATOR
Drug: Bevacizumab

Diclofenac

ACTIVE COMPARATOR
Drug: Diclofenac

Interventions

BevacizumabDRUG
Avastin
DiclofenacDRUG
Diclofenac

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with clinically significant macular edema and diffuse macular edema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Center

Tehran, Tehran Province, 166666, Iran

RECRUITING

MeSH Terms

Interventions

BevacizumabDiclofenac

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Central Study Contacts

Masoud Soheilian, MD

CONTACT

+982122585952labbafi@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2009

First Posted

October 22, 2009

Study Start

July 1, 2009

Last Updated

May 4, 2010

Record last verified: 2009-10

Locations

IR(1)