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

Primary Purpose

Age-Related Macular Degeneration

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranibizumab
Ranibizumab plus Photodynamic therapy
Sponsored by
Illinois Retina Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Age-Related Macular Degeneration, Ranibizumab, Lucentis, Photodynamic Therapy, Verteporfin, Visudyne

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Illinois Retina Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.

Secondary Outcome Measures

Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Determination of change in visual acuity from baseline.
Determination of change in retinal thickness by optical coherence tomography (OCT).
Determination of change in angiographic leakage from CNV.

Full Information

First Posted
May 16, 2008
Last Updated
March 27, 2012
Sponsor
Illinois Retina Associates
Collaborators
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00680498
Brief Title
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
Acronym
CLOVER
Official Title
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Illinois Retina Associates
Collaborators
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Age-Related Macular Degeneration, Ranibizumab, Lucentis, Photodynamic Therapy, Verteporfin, Visudyne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Ranibizumab 0.5 mg
Intervention Type
Drug
Intervention Name(s)
Ranibizumab plus Photodynamic therapy
Other Intervention Name(s)
Lucentis, Visudyne
Intervention Description
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)
Primary Outcome Measure Information:
Title
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.
Time Frame
1 year
Title
Determination of change in visual acuity from baseline.
Time Frame
1 year
Title
Determination of change in retinal thickness by optical coherence tomography (OCT).
Time Frame
1 year
Title
Determination of change in angiographic leakage from CNV.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline T Merrill, MD
Organizational Affiliation
Illinois Retina Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Illinois Retina Associates
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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