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

Sponsored by:	Fondazione G.B. Bietti, IRCCS
Information provided by:	Fondazione G.B. Bietti, IRCCS
ClinicalTrials.gov Identifier:	NCT00574093

Purpose

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).

Condition	Intervention	Phase
Neovascular Age Related Macular Degeneration	Drug: Ranibizumab; Verteporfin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Verteporfin Ranibizumab

U.S. FDA Resources

Further study details as provided by Fondazione G.B. Bietti, IRCCS:

Primary Outcome Measures:

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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

% 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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 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.

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

Ages Eligible for Study:	50 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574093

Contacts

Contact: Monica Varano, MD	+390685356727	m.varano@mclink.it
Contact: Adele Chiaravalloti, MD	+390685356727	a.chiaravalloti@libero.it

Locations

Italy
Fondazione G.B.Bietti-IRCCS	Recruiting
Rome, Italy, 00198
Contact: Annamaria Rocchi +390685356727 annamaria.rocchi@fondazionebietti.it
Principal Investigator: Monica Varano, MD
Sub-Investigator: Adele Chiaravalloti, MD
Sub-Investigator: Mariacristina Parravano, MD
Sub-Investigator: Barbara Boccassini, MD
Sub-Investigator: Domenico Schiano, MD
Sub-Investigator: Massimiliano Tedeschi, MD

Sponsors and Collaborators

Fondazione G.B. Bietti, IRCCS

Investigators

Principal Investigator:

Monica Varano, MD

Fondazione G.B. Bietti, IRCCS

More Information

No publications provided

Responsible Party:	Fondazione G.B. Bietti, IRCCS ( Monica Varano )
Study ID Numbers:	CBPD952AIT03
Study First Received:	December 13, 2007
Last Updated:	January 11, 2008
ClinicalTrials.gov Identifier:	NCT00574093 History of Changes
Health Authority:	Italy: Ethics Committee

Keywords provided by Fondazione G.B. Bietti, IRCCS:

combination therapy
Lucentis
Visudyne

Study placed in the following topic categories:

Photosensitizing Agents
Radiation-Sensitizing Agents
Eye Diseases
Verteporfin

Neoplasm Metastasis
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses
Eye Diseases
Physiological Effects of Drugs
Verteporfin

Retinal Degeneration
Macular Degeneration
Dermatologic Agents
Pharmacologic Actions
Retinal Diseases

ClinicalTrials.gov processed this record on September 11, 2009