Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD

NCT ID: NCT00574093

Last Updated: 2009-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-10-31

Brief Summary

This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne® [verteporfin for injection] and Lucentis™) on visual acuity outcomes. Study results will be submitted for publication to provide data that may help physicians refine the clinical management of patients with CNV secondary to age-related macular degeneration (AMD).

Detailed Description

This will be a single arm study. Patients will be administered Lucentis™ on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.

Consenting patients will participate in the Screening Period to evaluate study eligibility. Patient eligibility assessments will include BCVA, contrast sensibility, speed reading and VFQ-25, a standard ophthalmic examination, OCT, color fundus photography, Fluorescein Angiography (FA), Green Indocyanine Angiography, Microperimetry and multifocal ERG.

BCVA and mean central retinal thickness measured by OCT will be repeated at every follow up visit.

Fluorescein Angiography (FA), Green Indocyanine Angiography, contrast sensibility and speed reading mean retinal sensitivity measured by microperimetry will repeated at month 3, 6, 9 and 12 month.

Color fundus photography at month 1, 3, 6, 9 and 12 month. Multifocal ERG will repeated at month 3 and 12 month. VFQ-25 will repeated at month 3 and 12.

The patient will receive ranibizumab monthly unless the BCVA got worse than 5 letters from the baseline BCVA and / or mean central retinal thickness evaluated with OCT increased less than 100 µm compared to month 2 visit (last date treatment). The repetition of the dose of ranibizumab should not begin before the thirtieth day following the end of the previous treatment.

Conditions

Neovascular Age Related Macular Degeneration

Keywords

combination therapy; Lucentis; Visudyne

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

A: This will be a single arm study. Patients will be administered Lucentis™ on Day 1,at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.

Group Type: EXPERIMENTAL

Ranibizumab; Verteporfin

Intervention Type: DRUG

Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.

Interventions

Ranibizumab; Verteporfin

Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 50 years or older male or female patients of any race with subfoveal CNV secondary to AMD (all types of lesion).
• The total area of CNV encompassed within the lesion must be >50% of the total lesion area. The total lesion area must have the greatest linear dimension ≤5400 microns (9 MPS Disc Areas).
• BCVA letter score in the study eye should be between 73 and 24 (approximately 20/40 to 20/320 Snellen Equivalent) using an ETDRS chart measured at 4 meters distance.

Exclusion Criteria

• Any prior treatments with Visudyne, Macugen, Lucentis (Ranibizumab), Avastin (Bevacizumab) or other anti-angiogenic or corticosteroid intravitreal treatment in the study eye
• Prior external-beam radiation, subfoveal focal laser photocoagulation, transpupillary thermotherapy, pars plana vitrectomy in the study eye
• History of intraocular surgery in the study eye except for uncomplicated cataract surgery more than 90 days prior to treatment
• History of YAG-laser posterior capsulotomy in the study eye within 30 days prior treatment
• Use of non steroid antinflammatory drugs during the study
• Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia (>8 D)
• Presence of fibrosis, haemorrhage, pigment epithelial detachments or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion
• Tear (rip) of the retinal pigment epithelium
• Vitreal haemorrhage, retinal detachment or macular hole
• Epiretinal membrane
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with two or more topical pharmacological antiglaucomatous medication)
• Active or history of ocular inflammation or infection
• Aphakia and posterior capsule tear
• Pregnant or nursing (lactating) women
• Women of child-bearing potential unless they meet the following definition of postmenopausal
• Any systemic medical condition that may interferes with the safety of the patient
• Positive anamnesis for tumor in last the 5 years

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione G.B. Bietti, IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Fondazione G.B. Bietti, IRCCS

Principal Investigators

Monica Varano, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione G.B. Bietti, IRCCS

Locations

Fondazione G.B.Bietti-IRCCS

Rome, , Italy

Countries

Italy

Other Identifiers

CBPD952AIT03

Identifier Type: -

Identifier Source: org_study_id