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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00722384

Enrollment

Registered

2008-07-25

Start date

2004-08-31

Completion date

2007-12-31

Last updated

2008-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Degeneration

Keywords

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

Brief summary

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

Interventions

DRUGbevasiranib

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026