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

NCT00574093 | Completed Phase 2 DMC

• 1 other identifier: CBPD952AIT03
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Neovascular Age Related Macular Degeneration

Keywords

combination therapy; Lucentis; Visudyne

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• % 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

Study Arms (1)

A

EXPERIMENTAL

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.

Drug: Ranibizumab; Verteporfin

Interventions

Ranibizumab; Verteporfin 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.

A

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione G.B. Bietti, IRCCS: lead

Study Sites (1)

Fondazione G.B.Bietti-IRCCS

Rome, 00198, Italy

Location

MeSH Terms

Interventions

Ranibizumab; Verteporfin

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Monica Varano, MD

  Fondazione G.B. Bietti, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 14, 2007
• Study Start: January 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: October 1, 2009
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

IT (1)