Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-Based Retreatment - Full Text View

Sponsors and Collaborators:	Illinois Retina Associates Novartis
Information provided by:	Illinois Retina Associates
ClinicalTrials.gov Identifier:	NCT00680498

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 IV

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab Verteporfin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-Based Retreatment

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 ]

Estimated Enrollment:	20
Study Start Date:	February 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Ranibizumab Ranibizumab 0.5 mg
2: Active Comparator	Drug: Ranibizumab plus Photodynamic therapy Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

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	Recruiting
Oak Park, Illinois, United States, 60304
Contact: Lisa Ramirez 708-660-8454 lisar@illinoisretina.com
Principal Investigator: Pauline T Merrill, MD
Sub-Investigator: Mathew W MacCumber, MD

Sponsors and Collaborators

Illinois Retina Associates

Novartis

Investigators

Principal Investigator:

Pauline T Merrill, MD

Illinois Retina Associates

More Information

Responsible Party:	Illinois Retina Associates SC ( Pauline Merrill MD )
Study ID Numbers:	Clover 1
Study First Received:	May 16, 2008
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00680498
Health Authority:	United States: Institutional Review Board

Keywords provided by Illinois Retina Associates:

Age-Related Macular Degeneration
Ranibizumab
Lucentis

Photodynamic Therapy
Verteporfin
Visudyne

Study placed in the following topic categories:

Eye Diseases
Verteporfin
Retinal Degeneration

Macular Degeneration
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Photosensitizing Agents
Radiation-Sensitizing Agents
Therapeutic Uses

Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009