Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5 - Full Text View

Sponsored by:	Opko Health, Inc.
Information provided by:	Opko Health, Inc.
ClinicalTrials.gov Identifier:	NCT00722384

Purpose

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

Condition	Intervention	Phase
Macular Degeneration	Drug: bevasiranib	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by Opko Health, Inc.:

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

Enrollment:	15
Study Start Date:	August 2004
Study Completion Date:	December 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 0.1 mg bevasiranib in the study eye	Drug: bevasiranib 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.
2: Experimental 0.33 mg bevasiranib in the study eye,	Drug: bevasiranib 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.
3: Experimental 1.0 mg bevasiranib in the study eye	Drug: bevasiranib 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.
4: Experimental 1.5 mg bevasiranib in the study eye	Drug: bevasiranib 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.
5: Experimental 3.0 mg bevasiranib in the study eye.	Drug: bevasiranib 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.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722384

Locations

United States, New Jersey
OPKO site
Morristown, New Jersey, United States

Sponsors and Collaborators

Opko Health, Inc.

More Information

No publications provided

Responsible Party:	Opko Health ( Denis O'Shaughnessy )
Study ID Numbers:	ACU101
Study First Received:	July 23, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00722384 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Opko Health, Inc.:

AMD
Macular Degeneration
Opko Health
Acuity Pharmaceuticals

bevasiranib
Cand5
Age-Related

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on September 11, 2009