Phase
Condition
Aging
Myopic Macular Degeneration
Macular Degeneration
Treatment
N/AClinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female Asian patients 50 years of age or greater.
Patients with primary or recurrent subfoveal CNV secondary to AMD, including thosewith predominantly classic, minimally classic or active occult lesions with no classiccomponent.
Patients who have a BCVA score between 73 and 24 letters (approximately 20/40 to 20/320 Snellen equivalent), inclusively, in the study eye.
Total area of CNV (including both classic and occult components) encompassed withinthe lesion must be >= 50% of the total lesion area
Total lesion area must be <= 12 disc areas
Exclusion
Exclusion Criteria:
Patients who have in the fellow eye a Snellen equivalent below 20/200
Presence of angioid streaks, presumed ocular histoplasmosis syndrome, myopia (exceeding -8 diopters), or CNV secondary to causes other than AMD in the study eye
Subfoveal fibrosis or atrophy in the study eye
Total area of CNV (including both classic and occult components) encompassed withinthe lesion must be >= 50% of the total lesion area
Total lesion area must be <= 12 disc areas
Vitreous hemorrhage, retinal tear or history of rhegmatogenous retinal detachment ormacular hole (Stage 3 or 4) in the study eye.
Active, or history of, ocular inflammation or infection in the study eye within thelast 30 days prior to screening.
Uncontrolled glaucoma in the study eye
Treatment in the study eye with verteporfin, external-beam radiation therapy,subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, ortranspupillary thermotherapy within 30 days prior to screening
Previous treatment with anti-angiogenic drugs (pegaptanib, ranibizumab, bevacizumab,anecortave acetate, corticosteroids, protein kinase C inhibitors, squalamine, siRNA,VEGF-Trap etc.) for neovascular AMD in the study eye. Treatment of the fellow eye ispermitted if administered > 30 days before screening.
History of intraocular surgery in the study eye including pars plana vitrectomy,except for uncomplicated cataract surgery more than 60 days prior to screening
History of YAG laser posterior capsulotomy in the study eye within 30 days prior toscreening
Study Design
Connect with a study center
Novartis Investigative Site
Daegu,
Korea, Republic ofSite Not Available
Novartis Investigative Site
Pusan,
Korea, Republic ofSite Not Available
Novartis Investigative site
Seoul,
Korea, Republic ofSite Not Available
Novartis Investigative Site
Kaohsiung,
TaiwanSite Not Available
Novartis Investigative Site
LinKou,
TaiwanSite Not Available
Novartis Investigative site
Taipei,
TaiwanSite Not Available
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