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

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bevasiranib
bevasiranib
Sponsored by
OPKO Health, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Macular Degeneration, Opko Health, Acuity Pharmaceuticals, bevasiranib, Cand5, Age-Related

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • OPKO site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

Arm Description

0.1 mg bevasiranib in the study eye

0.33 mg bevasiranib in the study eye,

1.0 mg bevasiranib in the study eye

1.5 mg bevasiranib in the study eye

3.0 mg bevasiranib in the study eye.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2008
Last Updated
July 24, 2008
Sponsor
OPKO Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00722384
Brief Title
Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
OPKO Health, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Macular Degeneration, Opko Health, Acuity Pharmaceuticals, bevasiranib, Cand5, Age-Related

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
0.1 mg bevasiranib in the study eye
Arm Title
2
Arm Type
Experimental
Arm Description
0.33 mg bevasiranib in the study eye,
Arm Title
3
Arm Type
Experimental
Arm Description
1.0 mg bevasiranib in the study eye
Arm Title
4
Arm Type
Experimental
Arm Description
1.5 mg bevasiranib in the study eye
Arm Title
5
Arm Type
Experimental
Arm Description
3.0 mg bevasiranib in the study eye.
Intervention Type
Drug
Intervention Name(s)
bevasiranib
Other Intervention Name(s)
Cand5
Intervention Type
Drug
Intervention Name(s)
bevasiranib
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
OPKO site
City
Morristown
State/Province
New Jersey
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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