NCT00813891

Brief Summary

The purpose of the investigators study is to look at the visual outcomes of Ranibizumab injections in combination with photodynamic therapy for the treatment of neovascular age-related macular degeneration.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2008

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

11 months

First QC Date

December 22, 2008

Last Update Submit

December 22, 2008

Conditions

Macular DegenerationVisual Acuity

Keywords

ranibizumabverteporfin

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline at 6 months in the best corrected visual acuity (VA) score using an early treatment diabetic retinopathy study eye chart at a starting distance of 4 meters.

    Monthly for a total of 12 months

Secondary Outcomes (1)

  • To determine the following: 1:Proportion of subjects who loose fewer than 15 letters from baseline visual acuity at 6 months 2: Proportion of subjects with VA of 20/200 or worse 3: Proportion of subjects with VA of 20/40 or better

    One year

Study Arms (3)

Pre-PDT

ACTIVE COMPARATOR

Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin.

Drug: Ranibizumab

Post-PDT

ACTIVE COMPARATOR

Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin.

Drug: Ranibizumab

No PDT

ACTIVE COMPARATOR

Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin.

Drug: Ranibizumab

Interventions

RanibizumabDRUG

Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin

Also known as: Lucentis the brand name of Ranibizumab
Pre-PDT

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization
  • must be 50 years of age or older
  • have a lesion whose total size is no more than 5400micrometres in greatest linear dimension in the study eye
  • CNV that is more than 50% obscured by blood
  • have best corrected visual acuity of 20/50-20/320 (Snellen equivalent)
  • have been assessed with the use of early treatment diabetic retinopathy study charts

You may not qualify if:

  • previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment
  • any permanent structural damage to the central fovea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Victoria Hospital and the Montreal Retinal Institute

Montreal, Quebec, H3Z 1P4, Canada

Location

Related Publications (22)

  • Bressler NM, Bressler SB, Congdon NG, Ferris FL 3rd, Friedman DS, Klein R, Lindblad AS, Milton RC, Seddon JM; Age-Related Eye Disease Study Research Group. Potential public health impact of Age-Related Eye Disease Study results: AREDS report no. 11. Arch Ophthalmol. 2003 Nov;121(11):1621-4. doi: 10.1001/archopht.121.11.1621.

    PMID: 14609922BACKGROUND

  • Klein R, Peto T, Bird A, Vannewkirk MR. The epidemiology of age-related macular degeneration. Am J Ophthalmol. 2004 Mar;137(3):486-95. doi: 10.1016/j.ajo.2003.11.069.

    PMID: 15013873BACKGROUND

  • Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.

    PMID: 15078664BACKGROUND

  • Friedman DS, O'Colmain BJ, Munoz B, Tomany SC, McCarty C, de Jong PT, Nemesure B, Mitchell P, Kempen J; Eye Diseases Prevalence Research Group. Prevalence of age-related macular degeneration in the United States. Arch Ophthalmol. 2004 Apr;122(4):564-72. doi: 10.1001/archopht.122.4.564.

    PMID: 15078675BACKGROUND

  • Bressler NM. Age-related macular degeneration is the leading cause of blindness.. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. No abstract available.

    PMID: 15108691BACKGROUND

  • Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, Mariotti SP. Global data on visual impairment in the year 2002. Bull World Health Organ. 2004 Nov;82(11):844-51. Epub 2004 Dec 14.

    PMID: 15640920BACKGROUND

  • Yannuzzi LA, Negrao S, Iida T, Carvalho C, Rodriguez-Coleman H, Slakter J, Freund KB, Sorenson J, Orlock D, Borodoker N. Retinal angiomatous proliferation in age-related macular degeneration. Retina. 2001;21(5):416-34. doi: 10.1097/00006982-200110000-00003.

    PMID: 11642370BACKGROUND

  • Holz FG, Pauleikhoff D, Klein R, Bird AC. Pathogenesis of lesions in late age-related macular disease. Am J Ophthalmol. 2004 Mar;137(3):504-10. doi: 10.1016/j.ajo.2003.11.026.

    PMID: 15013875BACKGROUND

  • Lopez PF, Sippy BD, Lambert HM, Thach AB, Hinton DR. Transdifferentiated retinal pigment epithelial cells are immunoreactive for vascular endothelial growth factor in surgically excised age-related macular degeneration-related choroidal neovascular membranes. Invest Ophthalmol Vis Sci. 1996 Apr;37(5):855-68.

    PMID: 8603870BACKGROUND

  • Frank RN, Amin RH, Eliott D, Puklin JE, Abrams GW. Basic fibroblast growth factor and vascular endothelial growth factor are present in epiretinal and choroidal neovascular membranes. Am J Ophthalmol. 1996 Sep;122(3):393-403. doi: 10.1016/s0002-9394(14)72066-5.

    PMID: 8794712BACKGROUND

  • Kvanta A, Algvere PV, Berglin L, Seregard S. Subfoveal fibrovascular membranes in age-related macular degeneration express vascular endothelial growth factor. Invest Ophthalmol Vis Sci. 1996 Aug;37(9):1929-34.

    PMID: 8759365BACKGROUND

  • Kliffen M, Sharma HS, Mooy CM, Kerkvliet S, de Jong PT. Increased expression of angiogenic growth factors in age-related maculopathy. Br J Ophthalmol. 1997 Feb;81(2):154-62. doi: 10.1136/bjo.81.2.154.

    PMID: 9059252BACKGROUND

  • Otani A, Takagi H, Oh H, Koyama S, Ogura Y, Matumura M, Honda Y. Vascular endothelial growth factor family and receptor expression in human choroidal neovascular membranes. Microvasc Res. 2002 Jul;64(1):162-9. doi: 10.1006/mvre.2002.2407. No abstract available.

    PMID: 12074642BACKGROUND

  • Rakic JM, Lambert V, Devy L, Luttun A, Carmeliet P, Claes C, Nguyen L, Foidart JM, Noel A, Munaut C. Placental growth factor, a member of the VEGF family, contributes to the development of choroidal neovascularization. Invest Ophthalmol Vis Sci. 2003 Jul;44(7):3186-93. doi: 10.1167/iovs.02-1092.

    PMID: 12824270BACKGROUND

  • Okamoto N, Tobe T, Hackett SF, Ozaki H, Vinores MA, LaRochelle W, Zack DJ, Campochiaro PA. Transgenic mice with increased expression of vascular endothelial growth factor in the retina: a new model of intraretinal and subretinal neovascularization. Am J Pathol. 1997 Jul;151(1):281-91.

    PMID: 9212753BACKGROUND

  • Schwesinger C, Yee C, Rohan RM, Joussen AM, Fernandez A, Meyer TN, Poulaki V, Ma JJ, Redmond TM, Liu S, Adamis AP, D'Amato RJ. Intrachoroidal neovascularization in transgenic mice overexpressing vascular endothelial growth factor in the retinal pigment epithelium. Am J Pathol. 2001 Mar;158(3):1161-72. doi: 10.1016/S0002-9440(10)64063-1.

    PMID: 11238064BACKGROUND

  • Krzystolik MG, Afshari MA, Adamis AP, Gaudreault J, Gragoudas ES, Michaud NA, Li W, Connolly E, O'Neill CA, Miller JW. Prevention of experimental choroidal neovascularization with intravitreal anti-vascular endothelial growth factor antibody fragment. Arch Ophthalmol. 2002 Mar;120(3):338-46. doi: 10.1001/archopht.120.3.338.

    PMID: 11879138BACKGROUND

  • Saishin Y, Saishin Y, Takahashi K, Lima e Silva R, Hylton D, Rudge JS, Wiegand SJ, Campochiaro PA. VEGF-TRAP(R1R2) suppresses choroidal neovascularization and VEGF-induced breakdown of the blood-retinal barrier. J Cell Physiol. 2003 May;195(2):241-8. doi: 10.1002/jcp.10246.

    PMID: 12652651BACKGROUND

  • Verteporfin Roundtable 2000 and 2001 Participants; Treatment of age-related macular degeneration with photodynamic therapy (TAP) study group principal investigators; Verteporfin in photodynamic therapy (VIP) study group principal investigators. Guidelines for using verteporfin (visudyne) in photodynamic therapy to treat choroidal neovascularization due to age-related macular degeneration and other causes. Retina. 2002 Feb;22(1):6-18. doi: 10.1097/00006982-200202000-00003.

    PMID: 11884872BACKGROUND

  • Gragoudas ES, Adamis AP, Cunningham ET Jr, Feinsod M, Guyer DR; VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group. Pegaptanib for neovascular age-related macular degeneration. N Engl J Med. 2004 Dec 30;351(27):2805-16. doi: 10.1056/NEJMoa042760.

    PMID: 15625332RESULT

  • Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.

    PMID: 17021318RESULT

  • 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.

    PMID: 17021319RESULT

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 ProteinsSerum GlobulinsGlobulins

Study Officials

  • John Galic, MD

    Montreal Retina Institute

    PRINCIPAL INVESTIGATOR

  • John Chen, MD

    Montreal Retina Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Galic, MD

CONTACT

514-285-8866

Karin Oliver, MD

CONTACT

514-285-8866karin.oliver@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2008

First Posted

December 23, 2008

Study Start

January 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 23, 2008

Record last verified: 2008-12

Locations

CA(1)