Clinical trial NCT01469156: Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy
Official title: Treatment of Polypoidal Choroidal Vasculopathy With High Dose Ranibizumab (Lucentis): A Phase I Safety Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: polypoidal choroidal vasculopathy
choroidal neovascularization
ranibizumab
Lucentis
Lead sponsor: Southeast Retina Center, Georgia
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2011-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Twenty eyes will be randomized will receive 3 consecutive monthly intravitreal 1.0 or 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months
timeFrame: 12 months
measure: Change in Mean Central Foveal Thickness From Baseline
timeFrame: 12 Months
measure: Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months
timeFrame: 12 Months
measure: Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
timeFrame: 3 Months
measure: Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
timeFrame: 6 months
measure: Number of Participants at Month 9 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
timeFrame: 9 Months
measure: Number of Participants at Month 12 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters
timeFrame: 12 Months
measure: Mean Change Best Corrected Visual Acuity at 4 Meters at Baseline, Month 3, Month 6, Month 9, and Month 12
timeFrame: 12 months
measure: Number of Participants at Month 3 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
timeFrame: 3 months
measure: Number of Participants at Month 6 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
timeFrame: 6 months
measure: Number of Participants at Month 9 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
timeFrame: 9 months
measure: Number of Participants at Month 12 With Best Corrected Visual Acuity Loss at 4 Meters of 5, 10 and 15 or More Letters
timeFrame: 12 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
Study officials:
affiliation: Southeast Retina Center
name: Dennis M. Marcus, M.D.
role: PRINCIPAL_INVESTIGATOR
References: