Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
This trial is active, not recruiting.
|Condition||polypoidal choroidal vasculopathy|
|Treatment||ranibizumab 0.5 or 2.0 mg/0.05 cc|
|Phase||phase 1/phase 2|
|Sponsor||Southeast Retina Center, Georgia|
|Start date||September 2011|
|End date||February 2015|
|Trial size||20 participants|
|Trial identifier||NCT01469156, FVF4916s|
This Phase I/II study will investigate the safety and tolerability of intravitreally administered 0.5mg and 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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Masking||double blind (subject, investigator)|
Incidence and severity of ocular and systemic adverse events will be compared between the 2.0mg and 0.5 mg groups.
time frame: 2 years
Male or female participants at least 18 years old.
- 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.
- 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 would pose a significant hazard to the subject if the investigational therapy were initiated.
- Participation in another simultaneous medical investigation or trial.
- Exclude other anti-VEGF agents as therapy options.
- History of previous subfoveal laser.
- Advanced glaucoma (IOP > 25 or cup/disc ration > 0.8)
- Any condition in the opinion of the investigator that would interfere with disease status/progression or jeopardize patients' participation in the study.
|Official title||Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.|
|Principal investigator||Dennis M. Marcus, M.D.|
|Description||Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 2.0 mg/0.5mg (3:1 ratio) Ranibizumab injection with the first injection occuring at Day 0 and second and third injection occuring at month 1 and month 2 respectively. Retreatment with intravitreal Ranibizumab or other therapies will be at the investigators discretion but guidelines for recommended retreatment.|
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