NCT02796183

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

1.2 years

First QC Date

June 7, 2016

Last Update Submit

June 9, 2016

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Central Macular Thickness

    one year (between May 2015 and May 2016)

Study Arms (1)

Diabetic macular edema

OTHER

Bevacizumab (Altuzan) was injected subconjunctival space of the patients.

Drug: Subconjunctival bevacizumab (Altuzan)

Interventions

Subconjunctival bevacizumab (Altuzan)DRUG

Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.

Diabetic macular edema

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 7, 2016

First Posted

June 10, 2016

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

June 10, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share