The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02796183
• Other study ID #: 2015-1
• Status: Completed
• Phase: N/A
• First received: June 7, 2016
• Last updated: June 9, 2016
• Start date: January 2015
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Neon Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Subconjunctival bevacizumab (Altuzan)
Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Neon Hospital	Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Macular Thickness		one year (between May 2015 and May 2016)	No