NCT02096874

Brief Summary

Ultra-wide field fluorescein angiography can detect the response of anti VGEF therapy such as Avastin on retinal ischemia in the setting of diabetic macular edema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

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

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

March 24, 2014

Last Update Submit

December 2, 2021

Conditions

Non-proliferative Diabetic RetinopathyProliferative Diabetic RetinopathyDiabetic Macular Edema

Keywords

Peripheral retinal ischemiaultra wide field fluorescein angiographyBevacizumab

Outcome Measures

Primary Outcomes (1)

  • Peripheral retinal ischemia

    Change in peripheral retinal ischemia after intravitreal bevacizumab injection in non proliferative diabetic retinopathy and proliferative diabetic retinopathy.

    24 weeks

Study Arms (1)

Bevacizumab

OTHER

Each study subject will recieve Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month.

Drug: Bevacizumab

Interventions

BevacizumabDRUG

Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month

Also known as: Avastin
Bevacizumab

Eligibility Criteria

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

You may qualify if:

  • Diabetic patients at age \>18year with DME
  • Scheduled for Avastin therapy
  • Adequate media to obtain OCT and UWFA

You may not qualify if:

  • Macular pathology of any etiology
  • Preexisting systemic disease causing retinal ischemia
  • Previous laser or anti-VEGF treatment in past 3 months
  • Previous retina surgery in past 2 months
  • Allergy to fluorescein dye
  • Psychiatric disorder, Alzheimer disease and Dementia or any other disorder precluding follow-up or continuation of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khaled Eye Specialist Hospital

Riyadh, 11462, Saudi Arabia

Location

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Saba al Rashaed, MD

    King Khaled Eye Specialist Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 26, 2014

Study Start

June 1, 2013

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

December 3, 2021

Record last verified: 2021-12

Locations

SA(1)