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The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

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ClinicalTrials.gov Identifier: NCT02796183
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
Ondokuz Mayıs University
Information provided by (Responsible Party):
Volkan YETER, Neon Hospital

Brief Summary:
This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Subconjunctival bevacizumab (Altuzan) Not Applicable

Detailed Description:
At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. The measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. The macular thickness measurements before and after injection were compared.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema
Study Start Date : January 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Diabetic macular edema
Bevacizumab (Altuzan) was injected subconjunctival space of the patients.
Drug: Subconjunctival bevacizumab (Altuzan)
Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.




Primary Outcome Measures :
  1. Central Macular Thickness [ Time Frame: one year (between May 2015 and May 2016) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having diffuse diabetic macular edema persisted at least 1 month
  • No intravitreal injection in last 3 months.
  • No retinal laser photocoagulation in last 6 months
  • Not have any other macular disease causing macular edema

Exclusion Criteria:

  • Having ischemic macula
  • Intravitreal injection in last 3 months.
  • Retinal laser photocoagulation in last 6 months
  • Have any other macular disease causing macular edema

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Responsible Party: Volkan YETER, MD, Neon Hospital
ClinicalTrials.gov Identifier: NCT02796183     History of Changes
Other Study ID Numbers: 2015-1
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors