Open Label Study for the Evaluation of Tolerability of Five Dose Levels of Cand5
This study has been completed.
Sponsor:
Opko Health, Inc.
Information provided by:
Opko Health, Inc.
ClinicalTrials.gov Identifier:
NCT00722384
First received: July 23, 2008
Last updated: July 24, 2008
Last verified: July 2008
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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:
age-related macular degeneration
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 |
|---|---|
|
Experimental: 1
0.1 mg bevasiranib in the study eye
|
Drug: bevasiranib
Other Name: Cand5
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.
|
|
Experimental: 2
0.33 mg bevasiranib in the study eye,
|
Drug: bevasiranib
Other Name: Cand5
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.
|
|
Experimental: 3
1.0 mg bevasiranib in the study eye
|
Drug: bevasiranib
Other Name: Cand5
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.
|
|
Experimental: 4
1.5 mg bevasiranib in the study eye
|
Drug: bevasiranib
Other Name: Cand5
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.
|
|
Experimental: 5
3.0 mg bevasiranib in the study eye.
|
Drug: bevasiranib
Other Name: Cand5
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 More Information
No publications provided
| Responsible Party: | Denis O'Shaughnessy, Opko Health |
| ClinicalTrials.gov Identifier: | NCT00722384 History of Changes |
| Other Study ID Numbers: | ACU101 |
| Study First Received: | July 23, 2008 |
| Last Updated: | July 24, 2008 |
| 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 |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013