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Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00722384
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : July 25, 2008
Sponsor:
Information provided by:
OPKO Health, Inc.

Tracking Information
First Submitted Date  ICMJE July 23, 2008
First Posted Date  ICMJE July 25, 2008
Last Update Posted Date July 25, 2008
Study Start Date  ICMJE August 2004
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2008)
Complications, including those related to the intravitreal injection, and adverse events, and loss of lines of best-corrected visual acuity, slit lamp findings, lens opacification, intraocular pressure, fundus findings, and laboratory findings.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2008)
Stabilization of visual acuity (prevention of loss of three or more lines on the ETDRS chart), stabilization of lesion size, lack of leakage of lesion, or decrease in subretinal fluid
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5
Official Title  ICMJE An Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5 by Single Intravitreal Injection in Patients With Wet Age-Related Macular Degeneration
Brief Summary To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE
  • Drug: bevasiranib
    Other Name: Cand5
  • Drug: bevasiranib
    The first three patients enrolled will receive 0.1 mg Cand5 in the study eye, the next three patients enrolled will receive 0.33 mg Cand5 in the study eye, the following three patients enrolled will receive 1.0 mg Cand5 in the study eye, the following three patients enrolled will receive 1.5 mg Cand5 in the study eye, and the remaining three patients enrolled will receive 3.0 mg Cand5 in the study eye. The third patient enrolled at each dose level will complete their two-week visit before the next dose level group may be treated.
Study Arms  ICMJE
  • Experimental: 1
    0.1 mg bevasiranib in the study eye
    Interventions:
    • Drug: bevasiranib
    • Drug: bevasiranib
  • Experimental: 2
    0.33 mg bevasiranib in the study eye,
    Interventions:
    • Drug: bevasiranib
    • Drug: bevasiranib
  • Experimental: 3
    1.0 mg bevasiranib in the study eye
    Interventions:
    • Drug: bevasiranib
    • Drug: bevasiranib
  • Experimental: 4
    1.5 mg bevasiranib in the study eye
    Interventions:
    • Drug: bevasiranib
    • Drug: bevasiranib
  • Experimental: 5
    3.0 mg bevasiranib in the study eye.
    Interventions:
    • Drug: bevasiranib
    • Drug: bevasiranib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2008)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with subfoveal predominantly classic, minimally classic and purely occult lesions, secondary to age related macular degeneration, with a total lesion size (including blood, atrophy/scar and neovascularization) of < 12 total disc areas, of which at least 50% are active CNV.
  • Patients must have visual acuity 20/50 to 20/320 in the study eye.
  • Patients must have better visual acuity in the fellow eye than the study eye.
  • Subretinal hemorrhage (if any) must comprise no more than 50% of total lesion size.

Exclusion Criteria:

  • Patients with concomitant eye disease, including glaucoma, uveitis, diabetic retinopathy, presence of pigment epithelial tears or rips, acute ocular or periocular infection in the study eye.
  • Patients with > 3 prior PDT treatments with Visudyne in the study eye.
  • Patients who received PDT in the study eye within eight weeks prior to the baseline angiography/photography.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00722384
Other Study ID Numbers  ICMJE ACU101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Denis O'Shaughnessy, Opko Health
Study Sponsor  ICMJE OPKO Health, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account OPKO Health, Inc.
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP