Safety & Efficacy Study Evaluating the Combination of Bevasiranib & Lucentis Therapy in Wet AMD (CARBON)

Age Related Macular Degeneration Clinical Trial

— CARBON  

Official title:

A Phase 3, Randomized, Double-masked, Parallel-assignment and Dose-finding Study of Intravitreal Bevasiranib Sodium, Administered Every 8 Weeks as Maintenance Therapy Following Three Injections of Lucentis® Compared With Lucentis® Monotherapy Every 4 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00557791
• Other study ID #: ACU302
• Status: Withdrawn
• Phase: Phase 3
• First received: November 13, 2007
• Last updated: March 5, 2015
• Start date: November 2009
• Est. completion date: July 2012

Study information

• Verified date: February 2011
• Source: OPKO Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the safety and effectiveness of three doses of intravitreal bevasiranib sodium as maintenance therapy for Age-Related Macular Degeneration following initiation of anti-VEGF therapy with three doses of Lucentis®.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients must be age 50 years or older

• Patients must have predominantly classic, minimally classic or occult with no classic lesions secondary to Age Related Macular Degeneration.

• The study eye must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen equivalent).

• Patients must be willing and able to return for scheduled monthly follow-up visits for two-years.

Exclusion Criteria:

• Prior pharmacologic treatment for AMD in the study (patients can not have previously received Avastin®/Lucentis®, Macugen®, or any other anti-VEGF agents, steroid treatments, PDT, radiation treatment, or any experimental therapies for AMD in the study eye)

• Any intraocular surgery of the study eye within 12 weeks of screening

• Previous posterior vitrectomy of the study eye

• Advanced glaucoma or intraocular pressure above 22 mm Hg in the study eye despite treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
• ranibizumab
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
OPKO Health, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy measure: The proportion of patients at week 60 in each group with a successful visual acuity outcome (as defined as avoidance of a 3, or more, line loss in vision).		60 weeks	No
Secondary	Time from tx initiation to 1st use of rescue		60 weeks	No
Secondary	Distribution of change in VA from baseline to 60 weeks		60 weeks	No
Secondary	Proportion of patients at week 60 with a 3, or more, line gain in vision		60 weeks	No