NCT01724385

Brief Summary

To evaluate the efficacy of intravitreal bevacizumab injections for treatment of proliferative diabetic retinopathy (PDR) with new dense vitreous hemorrhage (VH) after previous full panretinal photocoagulation (PRP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Shorter than P25 for phase_4

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

August 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2012

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

4 months

First QC Date

November 7, 2012

Last Update Submit

April 25, 2013

Conditions

Vitreous HemorrhageProliferative Diabetic Retinopathy

Keywords

bevacizumab,proliferative diabetic retinopathy,vitreous hemorrhage,

Outcome Measures

Primary Outcomes (1)

  • The percentage of eyes that vitreous hemorrhage has been completely resolved

    The patients with PDR and prior complete laser treatment who presented with new dense VH. All eyes were treated with intravitreal bevacizumab injection. Complete ophthalmic examination and/or ocular ultrasonography were performed at baseline and 1, 6, 12 weeks and 6, 9, 12 months after first injection.

    12 months

Secondary Outcomes (1)

  • The change in best corrected visual acuity (BCVA) from baseline

    12 months

Other Outcomes (1)

  • Numbers of injection

    12 months

Study Arms (1)

intravitreal bevacizumab injection

EXPERIMENTAL

intravitreal injection of bevacizumab 1.25 mg

Drug: intravitreal injection of bevacizumab

Interventions

intravitreal injection of bevacizumabDRUG

intravitreal injection of bevacizumab

Also known as: Avastin
intravitreal bevacizumab injection

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with diabetes mellitus
  • proliferative diabetic retinopathy
  • prior complete panretinal photocoagulation
  • presented with new dense vitreous hemorrhage

You may not qualify if:

  • one-eyed patient
  • previous intraocular surgery
  • severe lens opacity precluding fundus examination
  • advance glaucoma
  • history of thromboembolic events such as myocardial infarction and cerebrovascular accident
  • uncontrolled systemic hypertension, systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 110 mmHg
  • known coagulation abnormalities or current use of anticoagulant medications other than aspirin
  • known allergies to any relevant drugs in this study
  • evidence of external ocular infection such as conjunctivitis and significant blepharitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

MeSH Terms

Conditions

Vitreous Hemorrhage

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Eye HemorrhageEye DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Suthasinee Sinawat, M.D.

    Department of Ophthalmology, Faculty of Medicine, Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 9, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

TH(1)