Trial | NCT00680498  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ranibizumab ...

  • Study Participants

    10
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.
Study Started
Feb 28
2007
Primary Completion
Jul 31
2009
Study Completion
Oct 31
2009
Last Update
Mar 28
2012
Estimate

Drug Ranibizumab

Ranibizumab 0.5 mg

  • Other names: Lucentis

Drug Ranibizumab plus Photodynamic therapy

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

  • Other names: Lucentis, Visudyne

1 Active Comparator

2 Active Comparator

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
No Results Posted