Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment

NCT ID: NCT00680498

Last Updated: 2012-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-10-31

Brief Summary

This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group).

The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months.

The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

Ranibizumab 0.5 mg

2

Group Type: ACTIVE_COMPARATOR

Ranibizumab plus Photodynamic therapy

Intervention Type: DRUG

Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Interventions

Ranibizumab

Ranibizumab 0.5 mg

Intervention Type: DRUG

Ranibizumab plus Photodynamic therapy

Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Intervention Type: DRUG

Other Intervention Names

Lucentis; Lucentis; Visudyne

Eligibility Criteria

Inclusion Criteria

• Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
• Vision 20/40 to 20/800 Snellen equivalent
• Age > 50 years
• Ability to provide written informed consent and comply with study assessments for the full duration of the study

Exclusion Criteria

• Intraocular surgery or injection within 30 days prior to enrollment in the study eye
• Intravitreal triamcinolone within the past 6 months in the study eye
• History of prior PDT treatment in the study eye
• History of argon laser treatment of subfoveal CNV in the study eye
• Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
• Clinically significant intraocular inflammation in the study eye
• No light perception in the fellow eye
• Anterior segment opacity preventing adequate visualization of fundus for FA or OCT
• Are currently participating in another clinical trial
• Women of childbearing potential not using adequate contraception, as well as women who are breastfeeding
• Known sensitivity to study drug(s) or class of study drug(s)
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Use of any other investigational agent in the last 30 days

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Illinois Retina Associates

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pauline T Merrill, MD

Role: PRINCIPAL_INVESTIGATOR

Illinois Retina Associates

Locations

Illinois Retina Associates

Oak Park, Illinois, United States

Countries

United States

Other Identifiers

Clover 1

Identifier Type: -

Identifier Source: org_study_id