Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab

Overview

Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recurrence is the main limitation of the treatment. The changes of the CNV vascular structure is expected to provide information regarding recurrence. In the eyes that the vascular structure is clearly seen in indocyanine green angiography (ICGA), the vascular changes after ranibizumab injections will be investigated prospectively.

Full Title of Study: “A Prospective, Interventional Case Series, Effect of Lucentis on Indocyanine Angiographic Changes in Patients With Wet Age-related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2013

Detailed Description

For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures of CNV is investigated at baseline, 3 and 6 months using ICGA. Expected number of patients are 48 eyes from 4 centers, competitively.

Interventions

  • Drug: ranibizumab
    • 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.

Arms, Groups and Cohorts

  • Experimental: ranibizumab
    • 0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.

Clinical Trial Outcome Measures

Primary Measures

  • Caliber of Choroidal New Vessel (CNV)
    • Time Frame: 6 months
    • Caliber of the largest CNV is measured using a software of IVAN (developed by Wisconsin University) that measures a caliber of retinal vessels using a semi-automatic method. An indocyanine green angiography (ICGA) image showing the vascular structures of CNV was processed to invert black and white for the analysis. The image was loaded in the software, and the course of the arteriolar CNV was indicated manually. Then average thickness of the vascular segment was calculated.

Secondary Measures

  • Lesion Size of CNV
    • Time Frame: 6 months
    • Lesion size of CNV is measured in fluorescein angiography using software, and find correlation with caliber of choroidal new vessels.
  • Visual Acuity in ETDRS Letters
    • Time Frame: 6 months
    • Visual acuity was assessed using the ETDRS chart. The ETDRS chart includes 100 letters as the maximum possible score, and 0 letters read as the minimum possible score. Higher scores represents better functioning.
  • Visual Acuity Changes
    • Time Frame: baseline and 6 months
    • Visual acuity is measured at baseline and 6 months using ETDRS chart. The changes was calculated by visual acuity at 6 months minus visual acuity at baseline. Positive values represent improvement of visual acuity, and negative values represent worsening of visual acuity at 6 months compared to baseline.

Participating in This Clinical Trial

Inclusion Criteria

1. age >= 50 2. Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better 3. Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area. 4. Area of CNV clearly visible in ICGA is more than half of the total CNV area. Exclusion Criteria:

1. CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc) 2. Blocked fluorescence in ICGA is more than half of the total CNV area. 3. Disciform scar 4. Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months 5. Previous any treatment of photodynamic therapy or photocoagulation 6. Previous intraocular or periocular injection of steroid within 3 months 7. Previous intraocular surgery except cataract surgery 8. Vitreo-retinal interface disease on the macula 9. Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.) 10. Uncontrolled periocular or intraocular infection 11. History of hypersensitivity to ranibizumab treatment 12. Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pusan National University Hospital
  • Collaborator
    • Novartis
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ji Eun Lee, Associate professor – Pusan National University Hospital
  • Overall Official(s)
    • Ji Eun Lee, MH, PhD, Principal Investigator, Pusan National Universtiy Hospital

References

Wong TY, Knudtson MD, Klein R, Klein BE, Meuer SM, Hubbard LD. Computer-assisted measurement of retinal vessel diameters in the Beaver Dam Eye Study: methodology, correlation between eyes, and effect of refractive errors. Ophthalmology. 2004 Jun;111(6):1183-90. doi: 10.1016/j.ophtha.2003.09.039.

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.

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.

Spaide RF. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006 Jan;141(1):149-56. doi: 10.1016/j.ajo.2005.07.025.

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