Safety Study of 2.0mg Lucentis to Treat Polypoidal Choroidal Vasculopathy

NCT01469156 | Completed Phase 1 Results

• 1 other identifier: FVF4916s
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

polypoidal choroidal vasculopathy; choroidal neovascularization; ranibizumab; Lucentis

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (12)

• Mean Best Corrected Visual Acuity Letter Change at 4 Meters Between Baseline and 12 Months

  12 months

• Change in Mean Central Foveal Thickness From Baseline

  12 Months

• Mean Change From Baseline in Total Area of FA CNV Leakage Over 12 Months

  12 Months

• Number of Participants at Month 3 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters

  3 Months

• Number of Participants at Month 6 With Best Corrected Visual Acuity Gain of 5, 10, and 15 or More Letters

  6 months

Study Arms (2)

Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)

EXPERIMENTAL

Intraocular injection of 1.0 or 2.0 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met

Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc

Ranibizumab 0.5 mg

ACTIVE COMPARATOR

Intraocular injection of 0.5 mg/0.05 cc ranibizumab. Photodynamic therapy with visudyne or laser photocoagulation or intravitreal steroids may be considered as monotherapy or in combination with Ranibizumab at the investigator's discretion if rescue criteria are met

Drug: ranibizumab 0.5 or 2.0 mg/0.05 cc

Interventions

ranibizumab 0.5 or 2.0 mg/0.05 cc DRUG

ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.

Also known as: Lucentis

Ranibizumab 0.5 mg; Ranibizumab 1.0 or 2.0 mg (HIGH DOSE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southeast Retina Center, Georgia: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Dennis Marcus
• Organization: Southeast Retina Center

dmarcus@southeastretina.com

706-650-0061

Study Officials

• Dennis M. Marcus, M.D.

  Southeast Retina Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Dennis M. Marcus Principal Investigator

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 10, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 12, 2022
• Results First Posted: December 12, 2022

Record last verified: 2022-11

Locations

US (1)