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

Age-Related Macular Degeneration Clinical Trial

— CLOVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680498
• Other study ID #: Clover 1
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2008
• Last updated: March 27, 2012
• Start date: February 2007
• Est. completion date: October 2009

Study information

• Verified date: March 2012
• Source: Illinois Retina Associates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Ranibizumab
Ranibizumab 0.5 mg
• Ranibizumab plus Photodynamic therapy
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Locations

Country	Name	City	State
United States	Illinois Retina Associates	Oak Park	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Illinois Retina Associates	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.		1 year
Secondary	Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.		1 year
Secondary	Determination of change in visual acuity from baseline.		1 year
Secondary	Determination of change in retinal thickness by optical coherence tomography (OCT).		1 year
Secondary	Determination of change in angiographic leakage from CNV.		1 year