Efficacy of Ranibizumab in Combination With Photodynamic Therapy for Wet Age-Related Macular Degeneration
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Detailed Description
The main cause of severe vision loss in patients with age-related macular degeneration (AMD) is the development of choroidal neovascularization (CNV). This debilitating form of AMD affects the macula lutea, the central part of the retina, which is responsible for high resolution visual acuity. Characteristic findings in neovascular AMD include the development of new, abnormal blood vessels in the choroid layer beneath the macula otherwise known as CNV.
Current treatment options for this condition have included include laser therapy, photodynamic therapy (PDT), and intraocular injections (different types of anti-vascular endothelial growth factors) alone or in combination. While current treatments were demonstrated to slow the progression of vision loss, neither therapy was shown to significantly improve visual acuity.
Given their different modes of action, it is believed that combination therapy of Ranibizumab with PDT may lead to better visual outcomes and may result in an improved effect in treating AMD and therefore may help decrease the need for monthly Ranibizumab injections. After the first injection, regardless of which group the patient has been assigned to, they will receive Ranibizumab injections at 4 week intervals if clinically indicated. The purpose of the this study is to evaluate the visual outcomes of intraocular Ranibizumab injections in combination with photodynamic therapy with verteporfin for the treatment of neovascular AMD.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pre-PDT Participants in this group will receive an intraocular Ranibizumab injection one week prior to the first PDT with verteporfin. |
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week prior to PDT with verteporfin
Other Names:
|
| Active Comparator: Post-PDT Participants in this group will receive an intraocular Ranibizumab injection one week post the first PDT with verteporfin. |
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab one week after PDT with verteporfin
Other Names:
|
| Active Comparator: No PDT Participants in this group will receive an intraocular Ranibizumab injection with no accompanying PDT with verteporfin. |
Drug: Ranibizumab
Intraocular injection of 0.5mg of Ranibizumab with no accompanying PDT with verteporfin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
diagnosed with any subtype of primary subfoveal or juxtafoveal choroidal neovascularization
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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
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CNV that is more than 50% obscured by blood
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have best corrected visual acuity of 20/50-20/320 (Snellen equivalent)
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have been assessed with the use of early treatment diabetic retinopathy study charts
Exclusion Criteria:
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previous treatment (including verteporfin therapy) that could compromise an assessment of the study treatment
-
any permanent structural damage to the central fovea
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Royal Victoria Hospital and the Montreal Retinal Institute | Montreal | Quebec | Canada | H3Z 1P4 |
Sponsors and Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Investigators
- Principal Investigator: John Galic, MD, Montreal Retina Institute
- Principal Investigator: John Chen, MD, Montreal Retina Institute
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- Bressler NM. Age-related macular degeneration is the leading cause of blindness... JAMA. 2004 Apr 21;291(15):1900-1.
- Congdon N, O'Colmain B, Klaver CC, Klein R, Muñoz 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.
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- Klein R, Peto T, Bird A, Vannewkirk MR. The epidemiology of age-related macular degeneration. Am J Ophthalmol. 2004 Mar;137(3):486-95. Review.
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- 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.
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- Rakic JM, Lambert V, Devy L, Luttun A, Carmeliet P, Claes C, Nguyen L, Foidart JM, Noël 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.
- 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.
- 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.
- 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.
- 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. Review.
- Yannuzzi LA, Negrão 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.
- MUHC - 1234 - RVH