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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680498
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : March 28, 2012
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Illinois Retina Associates

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Ranibizumab Drug: Ranibizumab plus Photodynamic therapy Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
Study Start Date : February 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: Ranibizumab
Ranibizumab 0.5 mg
Other Name: Lucentis

Active Comparator: 2 Drug: Ranibizumab plus Photodynamic therapy
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
Other Names:
  • Lucentis
  • Visudyne

Primary Outcome Measures :
  1. To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision. [ Time Frame: 1 year ]
  2. Determination of change in visual acuity from baseline. [ Time Frame: 1 year ]
  3. Determination of change in retinal thickness by optical coherence tomography (OCT). [ Time Frame: 1 year ]
  4. Determination of change in angiographic leakage from CNV. [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00680498

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United States, Illinois
Illinois Retina Associates
Oak Park, Illinois, United States, 60304
Sponsors and Collaborators
Illinois Retina Associates
Novartis Pharmaceuticals
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Principal Investigator: Pauline T Merrill, MD Illinois Retina Associates

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Responsible Party: Illinois Retina Associates Identifier: NCT00680498    
Other Study ID Numbers: Clover 1
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012
Keywords provided by Illinois Retina Associates:
Age-Related Macular Degeneration
Photodynamic Therapy
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents