Back to results

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

Primary Purpose

Neovascular Age Related Macular Degeneration

Status

Completed

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Ranibizumab; Verteporfin

About this trial

This is an interventional treatment trial for Neovascular Age Related Macular Degeneration focused on measuring combination therapy, Lucentis, Visudyne

Eligibility Criteria

50 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fondazione G.B.Bietti-IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

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.

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

Full Information

NCT ID

NCT00574093

First Posted

December 13, 2007

Last Updated

October 29, 2009

Sponsor

Fondazione G.B. Bietti, IRCCS

1. Study Identification

Unique Protocol Identification Number

NCT00574093

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2009

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Fondazione G.B. Bietti, IRCCS

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Age Related Macular Degeneration

Keywords

combination therapy, Lucentis, Visudyne

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ranibizumab; Verteporfin

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

95 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Monica Varano, MD

Organizational Affiliation

Fondazione G.B. Bietti, IRCCS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fondazione G.B.Bietti-IRCCS

City

Rome

ZIP/Postal Code

00198

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs