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

NCT ID: NCT00722384

Last Updated: 2008-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2007-12-31

Brief Summary

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

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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AMD Macular Degeneration Opko Health Acuity Pharmaceuticals bevasiranib Cand5 Age-Related

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

0.1 mg bevasiranib in the study eye

Group Type EXPERIMENTAL

bevasiranib

Intervention Type DRUG

bevasiranib

Intervention Type DRUG

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.

2

0.33 mg bevasiranib in the study eye,

Group Type EXPERIMENTAL

bevasiranib

Intervention Type DRUG

bevasiranib

Intervention Type DRUG

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.

3

1.0 mg bevasiranib in the study eye

Group Type EXPERIMENTAL

bevasiranib

Intervention Type DRUG

bevasiranib

Intervention Type DRUG

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.

4

1.5 mg bevasiranib in the study eye

Group Type EXPERIMENTAL

bevasiranib

Intervention Type DRUG

bevasiranib

Intervention Type DRUG

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.

5

3.0 mg bevasiranib in the study eye.

Group Type EXPERIMENTAL

bevasiranib

Intervention Type DRUG

bevasiranib

Intervention Type DRUG

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.

Interventions

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bevasiranib

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Cand5

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OPKO Health, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Opko Health

Locations

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OPKO site

Morristown, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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ACU101

Identifier Type: -

Identifier Source: org_study_id