The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

June 9, 2016 updated by: Volkan YETER, Neon Hospital
This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Central Macular Thickness
Time Frame: one year (between May 2015 and May 2016)
one year (between May 2015 and May 2016)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neon Hospital

Collaborators

Ondokuz Mayıs University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimate)

June 10, 2016

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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