NCT00567372

Brief Summary

Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

November 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 3, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

November 30, 2007

Last Update Submit

May 31, 2024

Conditions

Diffuse Diabetic Macular Edema

Keywords

Diffuse diabetic macular edemasub-tenonBevacizumab

Outcome Measures

Primary Outcomes (1)

  • macular volume

    baseline, 3,6 and 12 weeks

Secondary Outcomes (2)

  • macular thickness

    baseline,3,6 and 12 weeks

  • best corrected visual acuity

    baseline, 3,6 and 12 weeks

Interventions

bevacizumab (Sub-tenon´s injection)DRUG

a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)

Eligibility Criteria

Age25 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asociación para Evitar la Ceguera en Mexico

Mexico City, Mexico City, 04030, Mexico

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sandra Vera, MD

    Asociación para Evitar la Ceguera en Mexico

    PRINCIPAL INVESTIGATOR

  • Hugo Quiroz-Mercado, MD

    Denver Health Medical Center

    PRINCIPAL INVESTIGATOR

  • Adai Pérez-Montesinos, MD

    Asociación para Evitar la Ceguera en Mexico

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2007

First Posted

December 4, 2007

Study Start

June 1, 2008

Primary Completion

November 1, 2008

Study Completion

June 1, 2009

Last Updated

June 3, 2024

Record last verified: 2024-05

Locations

ME(1)