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

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

Official Title
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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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: bevasiranib
* Drug: bevasiranib


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>0.1 mg bevasiranib in the study eye | Drug: bevasiranib<br> <br> * Other names: Cand5;Drug: bevasiranib<br>* 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.<br>|
| Experimental: 2<br>0.33 mg bevasiranib in the study eye, | Drug: bevasiranib<br> <br> * Other names: Cand5;Drug: bevasiranib<br>* 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.<br>|
| Experimental: 3<br>1.0 mg bevasiranib in the study eye | Drug: bevasiranib<br> <br> * Other names: Cand5;Drug: bevasiranib<br>* 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.<br>|
| Experimental: 4<br>1.5 mg bevasiranib in the study eye | Drug: bevasiranib<br> <br> * Other names: Cand5;Drug: bevasiranib<br>* 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.<br>|
| Experimental: 5<br>3.0 mg bevasiranib in the study eye. | Drug: bevasiranib<br> <br> * Other names: Cand5;Drug: bevasiranib<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, Macular Degeneration, Opko Health, Acuity Pharmaceuticals, bevasiranib, Cand5, Age-Related