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
1 other identifier
interventional
15
1 country
1
Brief Summary
To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 23, 2008
CompletedFirst Posted
Study publicly available on registry
July 25, 2008
CompletedJuly 25, 2008
July 1, 2008
3 years
July 23, 2008
July 24, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (5)
1
EXPERIMENTAL0.1 mg bevasiranib in the study eye
2
EXPERIMENTAL0.33 mg bevasiranib in the study eye,
3
EXPERIMENTAL1.0 mg bevasiranib in the study eye
4
EXPERIMENTAL1.5 mg bevasiranib in the study eye
5
EXPERIMENTAL3.0 mg bevasiranib in the study eye.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
OPKO site
Morristown, New Jersey, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 23, 2008
First Posted
July 25, 2008
Study Start
August 1, 2004
Primary Completion
August 1, 2007
Study Completion
December 1, 2007
Last Updated
July 25, 2008
Record last verified: 2008-07