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

Neovascular Age Related Macular Degeneration Clinical Trial

— Luvi  

Official title:

12 Months Case Series Open Study to Assess the Safety and Efficacy of Intravitreal Injection of Lucentis (Ranibizumab 0.5 mg)Used in Combination With Visudyne (Verteporfin PDT) in Naive Subjects With Subfoveal CNV Secondary to AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574093
• Other study ID #: CBPD952AIT03
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2007
• Last updated: October 29, 2009
• Start date: January 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: Fondazione G.B. Bietti, IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Italy	Fondazione G.B.Bietti-IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione G.B. Bietti, IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the mean change from baseline in BCVA letters with ETDRS at Month 3,6,12. -the number of retreatments, the treatment-free interval and the % of retreated patients at month 3, 6, 12. -the mean retinal thickness change from baseline at month 3, 6 and 12.		12 months	Yes
Secondary	% of patients that gain =5, =10, =15 letters BCVA; % of patients that lose <15 letters; Mean BCVA change and mean change of the total area of the lesion from baseline; Change of FA leakage; Mean retinal sensitivity change at month 3, 6 and 12		12 months	Yes