NCT00288561

CompletedPhase 2

Study of Ranibizumab Administered in Conjunction With Photod...

NCT00288561|CompletedPhase 2

Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration

Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)

Novartis

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

CRFB002B2201

Study Type

interventional

Reported enrollment (type unavailable)

N/A

Locations

1 country

Sites

1

Timeline

Study Start

November 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

July 2007

Actual (reported)

Brief Summary

Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): Not reported
Study completion date: July 2007
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
November 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
February 7, 2006
Actual (reported)
First Posted
February 8, 2006
Actual (reported)
Study Completion
July 2007
Actual (reported)

Last Updated: June 19, 2008
Status Verified: June 2008
Last Update Submitted: June 18, 2008

Conditions

Age-Related Macular Degeneration (ARMD)

Keywords

ARMD, ranibizumab, verteporfin

Interventions

ranibizumabDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients 50 years of age or greater who have provided written informed consent
Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component

Sponsors & Collaborators

Novartis
Industrylead

Study Sites (1)

Novartis

Basel, Switzerland

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

Novartis Customer Information
Novartis - Including Sites in Germany
STUDY CHAIR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

February 7, 2006

First Posted

February 8, 2006

Study Start

November 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

July 2007

Actual (reported)

NCT00826371

Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients

Phase 3Completed

NCT00891735

A Study of Ranibizumab Administered Monthly or on an As-needed Basis in Patients With Subfoveal Neovascular Age-related Macular Degeneration (HARBOR)

Phase 3Completed

NCT00423189

Lucentis Utilizing Visudyne (LUV Trial) Combination Therapy in the Treatment of Age-Related Macular Degeneration

Phase 4Terminated

NCT00331864

SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Phase 3Completed

NCT00056823

Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)

Phase 1/2Completed

NCT00500344

CAPTAIN:Choroidal Neovascularization Assessment by Pattern Electroretinography

Phase 1Completed

Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)

Willing to return for all scheduled visits

You may not qualify if:

\- Patients who have a BCVA of \< 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Contact the study team to confirm eligibility.

Serum Globulins

Globulins

Last Updated

June 19, 2008

Record last verified: 2008-06

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00288561
Data provider: ClinicalTrials.gov
Source updated: 2008-06-19
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:52 UTC

Locations

CH(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Keywords

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations