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

This study has been completed.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Illinois Retina Associates
ClinicalTrials.gov Identifier:
NCT00680498
First received: May 16, 2008
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
 Drug: Ranibizumab
Drug: Ranibizumab plus Photodynamic therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Illinois Retina Associates:

Primary Outcome Measures:
  • To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determination of change in visual acuity from baseline. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Determination of change in retinal thickness by optical coherence tomography (OCT). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Determination of change in angiographic leakage from CNV. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2007
Study Completion Date: October 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680498

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

No publications provided

Responsible Party: Illinois Retina Associates
ClinicalTrials.gov Identifier: NCT00680498     History of Changes
Other Study ID Numbers: Clover 1
Study First Received: May 16, 2008
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Illinois Retina Associates:
Age-Related Macular Degeneration
Ranibizumab
Lucentis
 Photodynamic Therapy
Verteporfin
Visudyne

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
 Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013