Combination Lucentis and Ocular Photodynamic Therapy With... | NCT00680498

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

NCT00680498

Sponsor

Illinois Retina Associates

Status

Completed

Last Update Posted

Mar 28, 2012Estimated

Enrollment

10Actual

Phase

Phase 4

Conditions

Age-Related Macular Degeneration

Interventions

Ranibizumab
Ranibizumab plus Photodynamic therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Jul 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

May 16, 2008

First Submission Date that Met QC Criteria

May 19, 2008

First Posted Date

May 20, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 27, 2012

Last Update Posted Date

Mar 28, 2012Estimated

Name	Class
Novartis Pharmaceuticals	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Ranibizumab
2	Active Comparator		Drug: Ranibizumab plus Photodynamic therapy

Name	Type	Description	Arm Group Labels	Other Names
Ranibizumab	Drug	Ranibizumab 0.5 mg	1	Lucentis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine whether combination treatment can maintain or improve visual acuity within 3 lines of baseline visual acuity.		1 year

Secondary Outcomes

Measure	Description	Time Frame
Determination of whether combination treatment can minimize the number of re-treatments required to stabilize vision.		1 year
Determination of change in visual acuity from baseline.		1 year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Pauline T Merrill, MD	Illinois Retina Associates	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Illinois Retina Associates		Oak Park	Illinois	60304	United States

Type	Date	Date Unknown
Release	Sep 1, 2012
Reset	Oct 2, 2012
Release	Mar 28, 2013
Reset	May 7, 2013

ID	Term
D008268	Macular Degeneration

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000069579	Ranibizumab
D010778	Photochemotherapy
D000077362	Verteporfin

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 1, 2012			Oct 2, 2012
Mar 28, 2013