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

Study Overview
=================
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.

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

Conditions
-----------------
Age-Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Ranibizumab
* Drug: Ranibizumab plus Photodynamic therapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Ranibizumab<br>* Ranibizumab 0.5 mg<br>* Other names: Lucentis;|
| Active Comparator: 2<br> | Drug: Ranibizumab plus Photodynamic therapy<br>* Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)<br>* Other names: Visudyne;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision. |  | 1 year | 
| Determination of change in visual acuity from baseline. |  | 1 year | 
| Determination of change in retinal thickness by optical coherence tomography (OCT). |  | 1 year | 
| Determination of change in angiographic leakage from CNV. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age-Related Macular Degeneration, Ranibizumab, Lucentis, Photodynamic Therapy, Verteporfin, Visudyne