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Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

Primary Purpose

Choroidal Neovascularization, Age-Related Macular Degeneration

Status

Completed

Phase

Phase 3

Locations

Switzerland

Study Type

Interventional

Intervention

intravitreal ranibizumab

intravitreal ranibizumab & photodynamic therapy

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring subfoveal choroidal neovascularization (CNV), age-related macular degeneration, ranibizumab monotherapy, combined verteporfin-therapy, Lucentis® (ranibizumab), Visudyne®, photodynamic therapy

Eligibility Criteria

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

Inclusion Criteria:

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)
  - 10% 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)

Exclusion Criteria:

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

Sites / Locations

University Eye Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

intravitreal ranibizumab used in combination with verteporfin photodynamic therapy

intravitreal ranibizumab

Outcomes

Primary Outcome Measures

First injection with PDT

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00429962

First Posted

January 31, 2007

Last Updated

April 6, 2009

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT00429962

Brief Title

Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

Official Title

Randomized, Phase IIIb Study Comparing Safety, Tolerability and Efficacy Between Lucentis® Administered in Conjunction With PDT With Visudyne® and Lucentis® in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee

5. Study Description

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

Detailed Description

Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD. However, the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly formed vessels. The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintaining/improving the increase in vision improvement observed with ranibizumab monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy

6. Conditions and Keywords

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

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

intravitreal ranibizumab used in combination with verteporfin photodynamic therapy

Arm Title

Arm Type

Active Comparator

Arm Description

intravitreal ranibizumab

Intervention Type

Drug

Intervention Name(s)

intravitreal ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

intraocular injection

Intervention Type

Drug

Intervention Name(s)

intravitreal ranibizumab & photodynamic therapy

Other Intervention Name(s)

Visudyne

Intervention Description

intraocular injection photodynamic treatment (LASER) after intravenous injection

Primary Outcome Measure Information:

Title

First injection with PDT

Time Frame

monthly

Secondary Outcome Measure Information:

Title

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

Time Frame

monthly

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: 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) 10% 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) Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulrike Schneider, MD

Organizational Affiliation

University Eye Clinic Basel

Official's Role

Study Director

Facility Information:

Facility Name

University Eye Clinic

City

Basel

State/Province

Basel-Stadt

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

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Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

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