Off-Label AVASTIN (BEVACIZUMAB) For Serosanguinous Maculopathy

NCT00344617 | Unknown Phase 3

• 1 other identifier: R452/01/2006
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Choroidal Neovascularisation; Polypoidal Choroidal Vasculopathy

Keywords

Choroidal neovascularisation; Polypoidal choroidal vasculopathy; Intravitreal injection; Avastin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in OCT measured central retinal thickness

• Correlation in change in central retinal thickness and change in VA

Interventions

Bevacizumab (tradename: Avastin) DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Related Publications (2)

• 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. doi: 10.1016/j.ophtha.2005.02.007.

  PMID: 15936441 BACKGROUND

• 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.

  PMID: 16156152 BACKGROUND

MeSH Terms

Conditions

Choroidal Neovascularization; Polypoidal Choroidal Vasculopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Chong-Lye Ang, FRCOphth

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 23, 2006
• First Posted: June 27, 2006
• Study Start: June 1, 2006
• Study Completion: May 1, 2008
• Last Updated: September 26, 2007

Record last verified: 2007-09