Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

NCT00429962 | Completed Phase 3

• 1 other identifier: 081-PRC-2006-005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD

Conditions

Choroidal Neovascularization; Age-Related Macular Degeneration

Keywords

subfoveal choroidal neovascularization (CNV); age-related macular degeneration; ranibizumab monotherapy; combined verteporfin-therapy; Lucentis® (ranibizumab); Visudyne®; photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• First injection with PDT

  monthly

Secondary Outcomes (1)

• Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections

  monthly

Study Arms (2)

A

EXPERIMENTAL

intravitreal ranibizumab used in combination with verteporfin photodynamic therapy

Drug: intravitreal ranibizumab & photodynamic therapy

B

ACTIVE COMPARATOR

intravitreal ranibizumab

Drug: intravitreal ranibizumab

Interventions

intravitreal ranibizumab DRUG

intraocular injection

Also known as: Lucentis

B

intravitreal ranibizumab & photodynamic therapy DRUG

intraocular injection photodynamic treatment (LASER) after intravenous injection

Also known as: Visudyne

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:

• patients over 50 years, subfoveal CNV of any type secondary to age-related macular degeneration (AMD), no "macula-treatment for the last 30 days (e.g. with PDT, TA, Laser, Macugen®).
• the area of the CNV must occupy at least \>50% of the lesion (total lesion size under 5400 microns in greatest linear dimension)
• Occult CNV:
• recent disease progression
• bleeding
• VA decreased the last three months \>5 letters or 2 or more than two lines (Snellen)
• % increase of the lesion size the last three months
• Best corrected visual acuity score between 24-73 letters (20/40 to 20/320) (ETDRS 4 m)

You may not qualify if:

• Prior treatment with mit Laser, PDT, Macugen, TA
• Prior treatment with radiatio, vitrectomy, transpupillary thermotherapy
• History of surgical intervention in the study eye within two months preceding day 1
• concurrent use of systemic anti-VEGF agents
• previous treatment with or participation in a clinical trial involving anti-angiogenic drugs (Pegaptanib, ranibizumab, anecortave acetate of corticosteroids).
• Ocular disorders in the study eye that may confound interpretation of the study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases
• Retinal pigment epithelium tear, vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
• History of idiopathic or autoimmune-associated uveitis in either eye, active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye
• Extracapsular extraction of cataract with phacoemulsification within two months preceding day 1, or a history of post-operative complications within the last 12 months preceding day 1 or a history of post-operative complications within the last 12 months preceding day 1 in the study eye (uveitis, cyclitis, iritis etc.)
• Glaucoma with IOP\>25 mmHg despite therapy
• Aphakia or absence of the posterior capsule in the study eye
• Spherical equivalent \>-8

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Eye Clinic

Basel, Canton of Basel-City, 4031, Switzerland

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Ranibizumab; Photochemotherapy; Verteporfin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; 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

• Ulrike Schneider, MD

  University Eye Clinic Basel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 31, 2007
• First Posted: February 1, 2007
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: April 7, 2009

Record last verified: 2009-04

Locations

CH (1)