Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy (NCT01469156) | Clinical Trial Compass
CompletedPhase 1/2
Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
United States20 participantsStarted 2011-09
Plain-language summary
This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 1.0 or 2.0mg Ranibizumab in three monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month of drug safety follow up in subjects with exudative polypoidal choroidal vasculopathy (PCV) for a total of 24 months.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Males and Females \>18 years of age. Females of child bearing potential will undergo urine pregnancy testing and be required to use appropriate methods of birth control.
* ICG and fluorescein angiographic characteristics consistent with active, leaking PCV with subfoveal lesions and/or subfoveal hemorrhage, lipid exudates, PED or fluid diagnosed within the past 6 months or diagnosed as newly active within the past 6 months. Subjects who completed the 24 month follow up in the original FVF3671s protocol may enter the study without necessarily demonstrating active exudative PCV at enrollment.
* Best-Corrected ETDRS Visual Acuity at 4 meters between 20/20 - 20/800.
* Lesion size - no limitations.
* Lesions Characteristics - leaking lesions consistent with PCV. No limitations on hemorrhage, fibrosis or atrophy.
* No therapy (includes non foveal laser, PDT, intravitreal steroids, TTT, radiotherapy, or anti-VEGF therapy) or intraocular surgery within the past 30 days for any condition.
* Clear ocular media to allow for photography/angiography.
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Exclusion Criteria:
* Patients with features of age related macular degeneration such as abundant drusen and demographic features consistent with this diagnosis.
* Allergy to Fluorescein, ICG, Iodine, Shellfish.
* Pregnancy (positive pregnancy test)
* Any other condition that the investigator believes wo…
What they're measuring
1
Incidence and Severity of Ocular and Systemic Adverse Events Will be Compared Between the 2.0mg or 1.0mg (HIGH DOSE) and 0.5 mg Groups.