Trial | NCT00722384  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    bevasiranib ...

  • Study Participants

    15
To establish the tolerability and preliminary efficacy of Cand5 by a single intravitreal injection in patients with wet age-related macular degeneration.
Study Started
Aug 31
2004
Primary Completion
Aug 31
2007
Study Completion
Dec 31
2007
Last Update
Jul 25
2008
Estimate

Drug bevasiranib

  • Other names: 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.

1 Experimental

0.1 mg bevasiranib in the study eye

2 Experimental

0.33 mg bevasiranib in the study eye,

3 Experimental

1.0 mg bevasiranib in the study eye

4 Experimental

1.5 mg bevasiranib in the study eye

5 Experimental

3.0 mg bevasiranib in the study eye.

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.
No Results Posted