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

OPKO Health

Status and phase: Completed; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: bevasiranib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00722384

ACU101

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 55+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 5 patient groups

1

Experimental group

Description:

0.1 mg bevasiranib in the study eye

Treatment:

Drug: bevasiranib

Drug: bevasiranib

2

Experimental group

Description:

0.33 mg bevasiranib in the study eye,

Treatment:

Drug: bevasiranib

Drug: bevasiranib

3

Experimental group

Description:

1.0 mg bevasiranib in the study eye

Treatment:

Drug: bevasiranib

Drug: bevasiranib

4

Experimental group

Description:

1.5 mg bevasiranib in the study eye

Treatment:

Drug: bevasiranib

Drug: bevasiranib

5

Experimental group

Description:

3.0 mg bevasiranib in the study eye.

Treatment:

Drug: bevasiranib

Drug: bevasiranib