Polypoidal Choroidal Vasculopathy Clinical Trial
Official title:
Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.
Verified date | November 2022 |
Source | Southeast Retina Center, Georgia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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. |
Country | Name | City | State |
---|---|---|---|
United States | Southeast Retina Center | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Southeast Retina Center, Georgia | Genentech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Examples include 30 letter loss, major subretinal hemorrhage, involving 75% or more clinical macula (arcade to arcade), disease related vitreous hemorrhage, injection-related endophthalmitis, retinal detachment, vitreous hemorrhage, study drug/procedure - related uveitis, incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs. | 2 years | |
Secondary | Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months | 12 months | ||
Secondary | Change in Mean Central Foveal Thickness From Baseline | 12 Months | ||
Secondary | Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months | 12 Months | ||
Secondary | Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 3 Months | ||
Secondary | Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 6 months | ||
Secondary | Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 9 Months | ||
Secondary | Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters | 12 Months | ||
Secondary | Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12 | 12 months | ||
Secondary | Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 3 months | ||
Secondary | Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 6 months | ||
Secondary | Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 9 months | ||
Secondary | Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters | 12 months |
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