- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680498
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment (CLOVER)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Illinois
-
Oak Park, Illinois, United States, 60304
- Illinois Retina Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
|
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
Other Names:
|
Active Comparator: 1
|
Ranibizumab 0.5 mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Time Frame: 1 year
|
1 year
|
Determination of change in visual acuity from baseline.
Time Frame: 1 year
|
1 year
|
Determination of change in retinal thickness by optical coherence tomography (OCT).
Time Frame: 1 year
|
1 year
|
Determination of change in angiographic leakage from CNV.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Pauline T Merrill, MD, Illinois Retina Associates
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Clover 1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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