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)

Not Applicable

• Conditions: -H33; H33

• Registration Number: PER-163-08
• Lead Sponsor: EUROTECH,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-08
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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;
• Subjects presenting choroidal neovascularization due to causes other than AMD, including ocular histoplasmosis syndrome, angioid striae, multifocal choroiditis, zeroide ruptures or pathological myopia (spherical equivalent> 8 diopters or axial length> 25 mm);
• Subjects undergoing any type of intraocular surgery in the study eye in the 12 weeks prior to the pre-selection visit;
• Subjects with a previous posterior vitrectomy in the study eye;
• Subjects with a known severe allergy to fluorescein that is used in AFG;
• Subjects previously undergoing radiotherapy in the eye, head or neck;
• Subjects with an intravitreal device or medication in the study eye;
• Subjects with any other condition that, in the opinion of the investigator, may prevent the subject from completing the study (for example: dementia, mental illness);
• Subjects undergoing chronic treatment with systemic corticosteroids or other immunosuppressive therapy that may affect wound healing (for example, subjects who have undergone chemotherapy in the last 6 months) and subjects with any type of immune compromise (for example, HIV);
• Subjects with a history of optic neuritis;
• Subjects who have been previously diagnosed or who present retinal findings consistent with type 1 or type 2 diabetes mellitus;
• Prior intraocular surgery, except cataract surgery. If the subject has been operated on for cataracts, it must have been> 12 weeks before entering the study;
• Aphakia or absence of the posterior lens capsule in the study eye. The previous rupture of the posterior capsule is also exclusive, unless it is the result of a capsulotomy with laser and trio-aluminum-garnet (YAC) in relation to the previous implantation of an intraocular len

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:The safety of the NT-503 implant will be evaluated according to the following clinical results (its appearance does not necessarily require the explant of the device): -<br>1. Local adverse events: a. progression of a cataract, b. major changes in IOP, c. infectious endophthalmitis, d. severe eye inflammation<br>and. conjunctival erosion, f. retinal detachment and retinal tear, g. severe loss of visual acuity (AV) (> 3 lines in ETDRS), h. NVC progression<br>i. vitreous hemorrhage, j. related to the implant (extrusion, erosion, etc.)<br>2. Systemic adverse events: a. Abnormal findings in blood biochemistry, blood count, urine analysis / urinary biochemistry (abnormal indicates values outside the normal range or toxicity in clinical biochemistry grade II or higher), b. Symptoms of immunological disorders or allergy, c. Stroke, cardiac arrest or thrombosis<br>Measure:NT-503 implementation security<br>Timepoints:During the study<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Through the snell test<br>Measure:Better visual acuity with correction<br>Timepoints:During the study<br>;<br>Outcome name:Measurement of the thickness of the macula during the study.<br>Measure:Change in macula thickness (OGT)<br>Timepoints:During the study<br>;<br>Outcome name:Application of the questionnaire on visual function (NEI-VFQ25) during the study<br>Measure:Changes in the Visual Function Questionnaire (NEI-VFQ25)<br>Timepoints:During the study<br>