PER-163-08
Completed
未知
STUDY TO EVALUATE THE SAFETY AND VIABILITY OF THE IMPLEMENTATION OF NT-503 IN THE VITTURAL CAVITY FOR THE TREATMENT OF SUBFOVEAL COROID NEOVASCULARIZATION (NVC) SECONDARY TO AGE-ASSOCIATED MACULAR DEGENERATION (DMAE)
EUROTECH,0 sites0 target enrollmentMay 8, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EUROTECH,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must have an active NVC determined both by an AFG and by an OCT, with a total lesion size (including bleeding, scarring and neovascularization) \<12 papillary diameters in total (21\.24 mm ) and with a larger linear diameter (DLM) \<5\.4 mm;
- •The lesions can be both primary (newly diagnosed and untreated) and recurrent (previously diagnosed and with spontaneous regression, but presently present a new active component);
- •Subjects should have a better visual acuity in the study eye with correction between 69 and 24 letters on the ETDRS scale (equivalent to 20/40 \- 20/320 on the Snellen scale). Only one eye will be evaluated in the study. If both eyes of a subject are eligible, the one with the worst visual acuity will be selected for treatment and study. If only one of the two eyes is eligible, the vision in the eye in which the study is not performed must be 20/400 or better;
- •Minimally classic or hidden lesions without classic lesions should present evidence of an alleged recent progression of evolution, defined by: Presence of subretinal and / or liquid and / or lipid hemorrhage or Loss of one or more lines of vision (ETDRS scale or equivalent) during the last six months or lesion growth\> 10% in the last 6 months documented by AFG;
- •Subjects must be 50 years of age or older;
- •Subjects must be willing and able to attend scheduled treatment and follow\-up visits over a year;
Exclusion Criteria
- •Subjects with prior or simultaneous therapy for NVC, including thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy, injections of Macugen®, Lucentis® or Avastin®, intravitreal or subretinal steroids, transpupillary thermotherapy (TTT) and antiangiogenic systemic or intravitreal in the study eye. (Note: This criterion includes subjects for whom there is no known history, but who present photographic evidence of prior therapy);
- •Subretinal hemorrhage (if any) should not be more than 50% of the total size of the lesion; Thick submacular hemorrhages (defined as hemorrhages thicker than half the thickness of the retina, evaluated by OCT) should be excluded.
- •Subjects with concomitant diseases in the study eye, including uveitis, diabetic retinopathy, presence of tears in the pigmentary epithelium or acute ocular or periocular infections;
- •Subjects with advanced glaucoma (excavation ratio: papilla greater than 0\.8\) or with an intraocular pressure\> 30 mm Hg in the study eye;
- •Previous filtering surgery for glaucoma in the study eye;
- •Subjects with any type of retinal vasculopathy, including diabetic retinopathy, retinal venous occlusions, etc., in the study eye;
- •Subjects whose NVC lesion has, in the study eye, more than 25% scarring and / or atrophy;
- •Subjects with inadequate pupillary dilation or with significant opacities of the refractive media in the study eye, including cataracts, which may interfere with visual acuity or with the evaluation of the posterior segment;
- •Vitreous hemorrhage currently present in the study eye;
- •History of detachment of regmatogenous retina or macular hole in the study eye;
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Not Applicable
A STUDY TO EVALUATE THE SAFETY AND FEASIBILITY OF FOCAL EPIRETINAL RADIOTHERAPY AND RANIBIZUMAB (LUCENTIS®) FOR THE TREATMENT OF SUBFOVEAL CHOROIDAL NEOVASCULARIZATION (CNV) SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD)-H31H31PER-099-07EOVISTA INC.,
Withdrawn
Not Applicable
A Study to Evaluate the Feasibility and Safety of the Millipede Transcatheter Annuloplasty Ring System in Patients with Functional Mitral Regurgitatiorepair of the mitral valve - a backflow of blood within the heart due to the failure of the mitral valve to close properly10046973NL-OMON50054Boston Scientific Cooperation International10
Completed
Not Applicable
Safety and tolerability of a vaginal ointment without any active drugs in healthy women.ACTRN12617000778381Zenith Technology Corporation Limited9
Completed
Not Applicable
A Prospective Safety and Feasibility Study of the RejuvenAir* System Metered Cryospray Therapy for Chronic Bronchitis Patients.NL-OMON42706CSA MEDICAL, INC.15
Not yet recruiting
Not Applicable
Study to determine the safety and tolerability of combination therapy of TACE (Transarterial-chemoembolization) and Immunotherapy With the Autologous Killer Cell in patients with hepatocellular carcinoma: An open label studyKCT0007346Bundang CHA General Hospital10