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

Illinois Retina Associates

Status and phase

Completed

Phase 4

Conditions

Age-Related Macular Degeneration

Treatments

Drug: Ranibizumab

Drug: Ranibizumab plus Photodynamic therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00680498

Clover 1

Details and patient eligibility

About

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.

Enrollment

10 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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