Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy

This study is ongoing, but not recruiting participants.

First Received: June 23, 2006 Last Updated: September 25, 2007 History of Changes

Sponsored by:	Singapore National Eye Centre
Information provided by:	Singapore National Eye Centre
ClinicalTrials.gov Identifier:	NCT00344617

Purpose

To assess the use of Avastin for the management of serosanguinous maculopathy

Condition	Intervention	Phase
Choroidal Neovascularisation Polypoidal Choroidal Vasculopathy	Drug: Bevacizumab (tradename: Avastin)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Off-Label Use of AVASTIN (BEVACIZUMAB)Intravitreal Injection For the Treatment of Serosanguinous Maculopathy

Resource links provided by NLM:

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:

Change from baseline in VA, i.e. gain or loss of 5 letters (1 line), 15 letters (3 lines) or 30 letters (6 lines)

Secondary Outcome Measures:

Change in OCT measured central retinal thickness
Correlation in change in central retinal thickness and change in VA

Estimated Enrollment:	50
Study Start Date:	June 2006
Estimated Study Completion Date:	May 2008

Show Detailed Description

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All subfoveal/juxtafoveal CNV and PCV (polypoidal choroidal vasculopathy) who are not eligible for other treatment options (compassionate use)
CNV and PCV lesions which have failed PDT, conventional argon laser photocoagulation (salvage use)
CNV and PCV lesions treatable with PDT, but cannot afford or refused

Exclusion Criteria:

Patients with uncontrolled hypertension (systolic BP greater than 150mmHg or diastolic BP greater than 90mmHg
History of thrombolic events such as myocardial infarction or cerebral vascular accident
Renal abnormalities (as defined by established history of chronic renal disease or renal failure as well as patients requiring dialysis).
Recent (as defined as the past 28 days) or planned (as defined as the next 3 months) surgery.
Coagulation abnormalities, including anti-coagulant medication other than aspirin
Patients with peptic ulcer disease
Pregnant or lactating females

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344617

Sponsors and Collaborators

Singapore National Eye Centre

Investigators

Principal Investigator:

Chong-Lye Ang, FRCOphth

Singapore National Eye Centre

More Information

Publications:

Michels S, Rosenfeld PJ, Puliafito CA, Marcus EN, Venkatraman AS. Systemic bevacizumab (Avastin) therapy for neovascular age-related macular degeneration twelve-week results of an uncontrolled open-label clinical study. Ophthalmology. 2005 Jun;112(6):1035-47.

Rosenfeld PJ, Moshfeghi AA, Puliafito CA. Optical coherence tomography findings after an intravitreal injection of bevacizumab (avastin) for neovascular age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2005 Jul-Aug;36(4):331-5.

Study ID Numbers:	R452/01/2006
Study First Received:	June 23, 2006
Last Updated:	September 25, 2007
ClinicalTrials.gov Identifier:	NCT00344617 History of Changes
Health Authority:	Singapore: Domain Specific Review Boards; Singapore: Health Sciences Authority

Keywords provided by Singapore National Eye Centre:

Choroidal neovascularisation
Polypoidal choroidal vasculopathy
Intravitreal injection
Avastin

Study placed in the following topic categories:

Uveal Diseases
Eye Diseases
Metaplasia
Choroid Diseases

Bevacizumab
Neovascularization, Pathologic
Angiogenesis Inhibitors
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Antineoplastic Agents
Eye Diseases
Growth Substances
Choroid Diseases
Physiological Effects of Drugs
Bevacizumab
Angiogenesis Inhibitors

Pharmacologic Actions
Choroidal Neovascularization
Pathologic Processes
Therapeutic Uses
Metaplasia
Growth Inhibitors
Neovascularization, Pathologic
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on September 11, 2009