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Macular DegenerationPhase 3NCT00061594

A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration

A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Macular Degeneration, run by Genentech, Inc. at 82 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
rhuFab V2 (ranibizumab)
How many people
426 participants
Where
82 sitesin 6 countries
Study dates
May 2003to Sep 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent
  • Age >=50 years
  • Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling
  • Future treatment with PDT using verteporfin anticipated or expected in the study eye
  • Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye
  • A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is >=50% of the total lesion size
  • Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)
  • Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye

Who cannot join

  • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye
  • Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
  • Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
  • Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
  • Previous subfoveal focal laser photocoagulation in the study eye
  • Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
Show all 31Show fewer
  • History of vitrectomy surgery in the study eye
  • History of submacular surgery or other surgical intervention for AMD in the study eye
  • Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
  • Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either >=50% of the total lesion area or >=1 disc area (DA) in size
  • Subfoveal fibrosis or atrophy in the study eye
  • CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
  • Retinal pigment epithelial tear involving the macula in the study eye
  • Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
  • Active intraocular inflammation (grade trace or above) in the study eye
  • Current vitreous hemorrhage in the study eye
  • History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
  • Aphakia or absence of the posterior capsule in the study eye
  • Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
  • Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
  • Uncontrolled glaucoma in the study eye (defined as intraocular pressure >=30 mmHg despite treatment with anti-glaucoma medication)
  • History of glaucoma filtering surgery in the study eye
  • History of corneal transplant in the study eye
  • Premenopausal women not using adequate contraception
  • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
  • Current treatment for active systemic infection
  • History of allergy to fluorescein, not amenable to treatment
  • Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center
  • Inability to comply with study or follow up procedures

Trial locations and contacts

82 sites in 6 countries.

82 sites in 6 countries

United States70 sites

  • Lions Eye Institute

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48105

  • Retina Associates PC

    Annapolis, Maryland, 21401

  • Western Carolina Retinal Associates, PA

    Asheville, North Carolina, 28803

  • Retina & Vitreous Center of So. Oregon

    Ashland, Oregon, 97520

  • Emory University

    Atlanta, Georgia, 30322

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • Austin Retina Associates

    Austin, Texas, 78705

  • Brian Berger, MD P.A.

    Austin, Texas, 78705

  • Retina Associates of Cleveland

    Beachwood, Ohio, 44122

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • New England Eye Center

    Boston, Massachusetts, 02111

  • Center for Eye Research

    Boston, Massachusetts, 02114

  • Pennsylvania Retina Specialists

    Camp Hill, Pennsylvania, 17011

  • Retina Consultants of Charleston

    Charleston, South Carolina, 29414

  • Southeast Clinical Research

    Charlotte, North Carolina, 28210

  • Flavio Company

    Cincinnati, Ohio, 45242

  • Cleveland Clinic Foundation/Cole Eye Institute

    Cleveland, Ohio, 44195

  • Palmetto Retina Center

    Columbia, South Carolina, 29204

  • Midwest Retina

    Columbus, Ohio, 43215

  • Danbury Eye Physicians & Surgeons

    Danbury, Connecticut, 06810

  • Florida Retina Institute

    Daytona Beach, Florida, 32114

  • Retina Specialists

    DeSoto, Texas, 75115

  • Duke Univ Medical Center/Duke Eye Center

    Durham, North Carolina, 22710

  • Retina Group of Washington

    Fairfax, Virginia, 22031

  • Retina Associates of St. Louis

    Florissant, Missouri, 63031

  • Retina Vitreous Consultants

    Fort Lauderdale, Florida, 33334

  • Retina Consultants of Southwest Florida

    Fort Myers, Florida, 33901

  • Retina Health Center

    Fort Myers, Florida, 33901

  • UTMB

    Galveston, Texas, 77555

  • Associated Retinal Consultants

    Grand Rapids, Michigan, 49546

  • New England Retina Associates

    Hamden, Connecticut, 06518

  • Vitreoretinal Consultants

    Houston, Texas, 77030

  • Thomas A. Ciulla, MD, PC

    Indianapolis, Indiana, 46280

  • UC Irvine

    Irvine, California, 92697

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Southeastern Retina Associates, P.C.

    Knoxville, Tennessee, 37909

  • Delaware Valley Retina Associates

    Lawrenceville, New Jersey, 08648

  • Doheny Eye Institute

    Los Angeles, California, 90033

  • Retina Associates of South Florida

    Margate, Florida, 33063

  • Valley Retina Institute, P.A.

    McAllen, Texas, 78503

  • California Vitreoretinal Research Center

    Menlo Park, California, 94025

  • Bascom Palmer Eye Institute

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • No. California Retina-Vitreous Associates

    Mountain View, California, 94040

  • Retina Vitreous Associates

    Nashville, Tennessee, 37203

  • Retinal Associates of Oklahoma

    Oklahoma City, Oklahoma, 73120

  • Central Florida Retina

    Orlando, Florida, 32806

  • Retina Care Specialists

    Palm Beach Gardens, Florida, 33410

  • Bascom Palmer Eye Institute

    Palm Beach Gardens, Florida, 33418

  • Wills Eye Hospital

    Philadelphia, Pennsylvania, 19107

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • BH Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Ophthalmic Consultants of Long Island

    Rockville Centre, New York, 11570

  • Associated Retinal Consultants, P.C.

    Royal Oak, Michigan, 48073

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah, 84107

  • John Moran Eye Center/Univ of Utah

    Salt Lake City, Utah, 84132

  • Univ of Texas Health Science Center

    San Antonio, Texas, 78229

  • Medical Center Ophthalmology

    San Antonio, Texas, 78240

  • UCSF School of Medicine

    San Francisco, California, 94143

  • Ophthalmic Consultants

    Sarasota, Florida, 34239

  • Vitreoretinal Associates

    Seattle, Washington, 98104

  • Retina Consultants of Michigan

    Southfield, Michigan, 48034

  • St. Louis University Eye Institute

    St Louis, Missouri, 63104

  • Southern Vitreoretinal Associates PA

    Tallahassee, Florida, 32308

  • University of South Florida

    Tampa, Florida, 33612

  • Retina Vitreous Associates

    Toledo, Ohio, 43608

  • Retina Centers, P.C.

    Tucson, Arizona, 85704

  • University of Arizona

    Tucson, Arizona, 85711

  • New England Retina Consultants

    West Springfield, Massachusetts, 01089

Other trials in United States

Australia4 sites

  • University of Melbourne, Department of Ophthalmology

    East Melbourne, VIC-3002

  • Marsden Eye Research Pty Ltd

    Parramatta, NSW 2150

  • Save Sight Institute

    Sydney, NSW-2000

  • Westmead Hospital

    Westmead, NSW-2145

Other trials in Australia

France3 sites

  • Clinique d'Ophtalmologie

    Créteil, F-94010

  • Clinique Monticelli

    Marseille, F-13008

  • Hôpital Lariboisière

    Paris, F-75475

Other trials in France

Germany3 sites

  • Universitätsklinikum Bonn

    Bonn, D-53105

  • Universitatskliniken Koln

    Cologne, D-50924

  • Universitätsklinikum Leipzig

    Leipzig, D-04103

Other trials in Germany

Czechia1 site

  • Onci klinika FNKV

    Prague, 100 00

Other trials in Czechia

Hungary1 site

  • Semmelweis University, 1st Ophthalmological Department

    Budapest, H-1083

Other trials in Hungary

About this study

Official title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration

This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.

Being tested
rhuFab V2 (ranibizumab)
Keywords
Neovascular age-related macular degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rhuFab V2 (ranibizumab)Drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2003 (estimated)
  2. Study startMay 2003
  3. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
Double blind
Enrolment
426 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00061594
Sponsor's protocol ID
FVF2587g
Status last verified
Mar 2014
First submitted
29 May 2003
Last updated
19 Mar 2014
Results posted
No

Publications

  • Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.

    PubMed 17021319

  • Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. doi: 10.1016/j.ajo.2007.08.012. Epub 2007 Oct 22.

    PubMed 17949673

  • Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology. 2009 Jan;116(1):57-65.e5. doi: 10.1016/j.ophtha.2008.10.018.

    PubMed 19118696

  • Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.

    PubMed 19255158

  • Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J; Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) Research Group. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009 Jan;127(1):13-21. doi: 10.1001/archophthalmol.2008.562.

    PubMed 19139332

  • Thach AB, Yau L, Hoang C, Tuomi L. Time to clinically significant visual acuity gains after ranibizumab treatment for retinal vein occlusion: BRAVO and CRUISE trials. Ophthalmology. 2014 May;121(5):1059-66. doi: 10.1016/j.ophtha.2013.11.022. Epub 2014 Jan 11.

    PubMed 24424249

  • Weinberg DV, Shapiro H, Ehrlich JS. Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials. Ophthalmology. 2013 Jun;120(6):1278-82. doi: 10.1016/j.ophtha.2012.11.042. Epub 2013 Feb 28.

    PubMed 23453513

  • Bressler NM, Chang TS, Varma R, Suner I, Lee P, Dolan CM, Ward J, Ianchulev T, Fine J. Driving ability reported by neovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.

    PubMed 23009891

  • Rosenfeld PJ, Shapiro H, Ehrlich JS, Wong P; MARINA and ANCHOR Study Groups. Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials. Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.

    PubMed 21794843

  • Rosenfeld PJ, Shapiro H, Tuomi L, Webster M, Elledge J, Blodi B; MARINA and ANCHOR Study Groups. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials. Ophthalmology. 2011 Mar;118(3):523-30. doi: 10.1016/j.ophtha.2010.07.011.

    PubMed 20920825

  • Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol. 2010 Jun;149(6):939-946.e1. doi: 10.1016/j.ajo.2010.01.007. Epub 2010 Apr 8.

    PubMed 20378094

  • Bressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.

    PubMed 20189654

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing rhuFab V2 (ranibizumab) in people with Macular Degeneration, run by Genentech, Inc. at 82 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Australia, France, Germany, Czechia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00061594, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.

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