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

Phase 1

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: bevasiranib

• Registration Number: NCT00722384
• Lead Sponsor: OPKO Health, Inc.

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 available

Study Timeline

• Study Start: 2004-08
• Primary Completion: 2007-08
• Study Completion: 2007-12
• Status Verified: 2008-07
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-24
• Last Update Submitted: 2008-07-24
• Study First Posted: 2008-07-25
• Last Update Posted: 2008-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5	bevasiranib	3.0 mg bevasiranib in the study eye.
2	bevasiranib	0.33 mg bevasiranib in the study eye,
1	bevasiranib	0.1 mg bevasiranib in the study eye
3	bevasiranib	1.0 mg bevasiranib in the study eye
4	bevasiranib	1.5 mg bevasiranib in the study eye

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

OPKO site; 🇺🇸 Morristown, New Jersey, United States