NCT01626339

Brief Summary

Patients who will be scheduled for intravitreal injection of Ranibizumab or Bevacizumab will be recruited in this prospective self-controlled trial. Fundus photography will carried out at baseline immediately before injection and at 3, 7 days and 30 days after the first injection. Using image analysis software, measurements summarized as the central retinal artery equivalent (CRAE) and central retinal vein equivalent (CRVE). Null Hypothesis: There is no significant difference between arteriolar/venular diameter before and after injection of intravitreal ranibizumab/bevacizumab in the treated and untreated eye

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2012

Completed
Last Updated

June 22, 2012

Status Verified

June 1, 2012

Enrollment Period

2 months

First QC Date

June 20, 2012

Last Update Submit

June 21, 2012

Conditions

Keywords

Anti vascular endothelial growth factorretinal vessels

Interventions

Also known as: Lucentis
Also known as: Avastin

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who wish and need bevacizumab or ranibizumab treatment for underlying disease

You may not qualify if:

  • History of previous systemic or ocular Anti-VEGF therapy
  • History of previous intravitreal injection with any drug
  • Intraocular pressure ≥ 22
  • Glaucoma
  • History or presence of thromboembolic events
  • Un-controlled blood pressure
  • Blood donation during the previous 3 weeks
  • Relevant media opacity of the lens

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malaya Medical Center

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

RanibizumabBevacizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Mohammadreza Peyman, MD

CONTACT

Visvaraja Subrayan, Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

June 22, 2012

Study Start

April 1, 2012

Primary Completion

June 1, 2012

Last Updated

June 22, 2012

Record last verified: 2012-06

Locations