Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD
Information source: Fondazione G.B. Bietti, IRCCS
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neovascular Age Related Macular Degeneration
Intervention: Ranibizumab; Verteporfin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Fondazione G.B. Bietti, IRCCS Official(s) and/or principal investigator(s):
Monica Varano, MD, Principal Investigator, Affiliation: Fondazione G.B. Bietti, IRCCS
Overall contact:
Monica Varano, MD, Phone: +390685356727, Email: m.varano@mclink.it
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).
Clinical Details
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
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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.
Secondary outcome: % 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
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.
Eligibility
Minimum age: 50 Years.
Maximum age: 95 Years.
Gender(s): Both.
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
Locations and Contacts
Monica Varano, MD, Phone: +390685356727, Email: m.varano@mclink.it
Fondazione G.B.Bietti-IRCCS, Rome 00198, Italy; Recruiting
Annamaria Rocchi, Phone: +390685356727, Email: annamaria.rocchi@fondazionebietti.it
Monica Varano, MD, Principal Investigator
Adele Chiaravalloti, MD, Sub-Investigator
Mariacristina Parravano, MD, Sub-Investigator
Barbara Boccassini, MD, Sub-Investigator
Domenico Schiano, MD, Sub-Investigator
Massimiliano Tedeschi, MD, Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: June 2009
Last updated: January 11, 2008
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