Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

NCT00433017 | Terminated Phase 2 Results

• 1 other identifier: CBPD952A2309
• Study Type: interventional
• Target: 255
• Locations: 12 countries
• Sites: 12

Brief Summary

This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration

Conditions

Macular Degeneration; Choroidal Neovascularization

Keywords

Age-related macular degeneration; AMD; Choroidal neovascularization; Verteporfin; Ranibizumab

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.

  BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.

  Baseline and Month 12

• Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit

  The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.

  Month 2 to Month 11

Secondary Outcomes (3)

• Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12

  Month 12

• Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12

  Baseline and Month 12

• Mean Change in Central Retinal Thickness of the Study Eye at Month 12

  Baseline and Month 12

Study Arms (2)

Verteporfin + Ranibizumab

EXPERIMENTAL

Verteporfin (6 mg/m\^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).

Drug: Verteporfin Photodynamic Therapy; Drug: Ranibizumab

Ranibizumab Monotherapy

ACTIVE COMPARATOR

Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).

Drug: Ranibizumab; Drug: Placebo

Interventions

Verteporfin Photodynamic Therapy DRUG

After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of the infusion.

Also known as: Visudyne

Verteporfin + Ranibizumab

Ranibizumab DRUG

Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection

Also known as: Lucentis

Ranibizumab Monotherapy; Verteporfin + Ranibizumab

Placebo DRUG

As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.

Ranibizumab Monotherapy

Eligibility Criteria

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

You may qualify if:

• Subjects of either gender age 50 years or older
• Subfoveal choriodal neovascularization (CNV) due to age-related macular degeneration (AMD)

You may not qualify if:

• Choriodal neovascularization due to causes other than AMD
• Prior treatment for neovascular AMD in the study eye

Sponsors & Collaborators

• Novartis: lead

Study Sites (12)

Novartis Investigative site

Vienna, Austria

Location

Novartis Investigative site

Antwerp, Belgium

Location

Novartis Investigative site

Aalborg, Denmark

Location

Novartis Investigative site

Créteil, France

Location

Novartis Investigative site

Regensburg, Germany

Location

Novartis Investigative site

Budapest, Hungary

Location

Novartis Investigative site

Florence, Italy

Location

Novartis Investigative site

Rotterdam, Netherlands

Location

Novartis Investigative site

Warsaw, Poland

Location

Novartis Investigative site

Madrid, Spain

Location

Novartis Investigative site

Geneva, Switzerland

Location

Novartis Investigative site

Manchester, United Kingdom

Location

Related Publications (2)

• Ritter M, Simader C, Bolz M, Deak GG, Mayr-Sponer U, Sayegh R, Kundi M, Schmidt-Erfurth UM. Intraretinal cysts are the most relevant prognostic biomarker in neovascular age-related macular degeneration independent of the therapeutic strategy. Br J Ophthalmol. 2014 Dec;98(12):1629-35. doi: 10.1136/bjophthalmol-2014-305186. Epub 2014 Jul 30.

  PMID: 25079064 DERIVED

• Larsen M, Schmidt-Erfurth U, Lanzetta P, Wolf S, Simader C, Tokaji E, Pilz S, Weisberger A; MONT BLANC Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month MONT BLANC study results. Ophthalmology. 2012 May;119(5):992-1000. doi: 10.1016/j.ophtha.2012.02.002. Epub 2012 Mar 17.

  PMID: 22424834 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Verteporfin; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis

  Novartis

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 8, 2007
• First Posted: February 9, 2007
• Study Start: May 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 21, 2011
• Results First Posted: February 4, 2011

Record last verified: 2011-04

Locations

AU (1); NL (1); BE (1); DK (1); IT (1); PL (1); CH (1); FR (1); HU (1); DE (1); GB (1); ES (1)