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

This study has been withdrawn prior to enrollment.
(Study never initiated)
Sponsor:
Information provided by:
OPKO Health, Inc.
ClinicalTrials.gov Identifier:
NCT00557791
First received: November 13, 2007
Last updated: February 16, 2011
Last verified: February 2011
  Purpose

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®.


Condition Intervention Phase
Age Related Macular Degeneration
Drug: Bevasiranib
Drug: ranibizumab
Phase 3

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

Resource links provided by NLM:


Further study details as provided by OPKO Health, Inc.:

Primary Outcome Measures:
  • 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). [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from tx initiation to 1st use of rescue [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Distribution of change in VA from baseline to 60 weeks [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients at week 60 with a 3, or more, line gain in vision [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 0
Study Start Date: November 2009
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Lucentis® (0.5 mg) every 4 weeks.
Drug: ranibizumab
Lucentis® (0.5 mg) administered intravitreally every 4 weeks.
Other Name: Lucentis®
Experimental: B
Bevasiranib (1.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
Drug: Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
Experimental: C
Bevasiranib (2.0 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
Drug: Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks
Experimental: D
Bevasiranib (2.5 mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.
Drug: Bevasiranib
Three doses (1.0mg, 2.0mg, 2.5mg) of bevasiranib administered intravitreally every 8 weeks

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00557791

Sponsors and Collaborators
OPKO Health, Inc.
Investigators
Study Director: Naveed Shams, MD SVP at Opko Health
  More Information

No publications provided

Responsible Party: Naveed Shams, Opko Health
ClinicalTrials.gov Identifier: NCT00557791     History of Changes
Other Study ID Numbers: ACU302
Study First Received: November 13, 2007
Last Updated: February 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by OPKO Health, Inc.:
AMD
ARMD
Exudative Macular Degeneration
Bevasiranib
siRNA

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014