None listed
Conditions
Interventions
Group A Type of group
A single surgical procedure with the Epi-Rad90 Ophthalmic System and two injections of Lucentis® (0.5 mg) The first injection will be administered immediately after the intervention and the second will be administered during the visit corresponding to month 1
Group name:Group B Type of group
The first three injections of Lucentis® (0.5 mg) given monthly, followed by injections every three months for two years.
Sponsors
NEOVISTA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: • Subjects must present predominantly classic, minimally classic or occult lesions without classic lesions, determined by the investigator, secondary to DMAE, with a total lesion size (including blood, scar deformity and neovascularization) of 10% during the last 6 months; • Subjects must be 50 years of age or older; • Subjects must be willing to return for scheduled treatment and follow-up exams for three years and be able to do so; • Women must be postmenopausal for 1 year or more or have undergone surgical sterilization. Otherwise, it will be necessary to perform a blood pregnancy test in the 14 days prior to randomization and this test should give a negative result.
Exclusion criteria
Exclusion criteria: • Subjects with previous or simultaneous treatment for subfoveolar CNV, including thermal laser photocoagulation (with or without photographic signs), photodynamic treatment, injections with Macugen®, steroids administered by intravitreal or subretinal injection, transpupillary thermotherapy (TTT) and antiangiogenic agents administered through intravitreal injection or systemic antiangiogenic agents in the studied eye. (Note: Subjects without known antecedents are included, but with photographic signs of previous treatment); • Subjects with concomitant disease in the eye studied, including uveitis, diabetic retinopathy, presence of tears in the retinal epithelium, acute periocular or ocular infection; • Subjects with advanced glaucoma (greater than a digging index / papilla of 0.8) or intraocular pressure> 30 mmHg in the studied eye; • Previous filtration surgery of glaucoma in the eye under study. • Subjects with retinal vasculopathies, including diabetic retinopathy, obstruction of retinal veins, etc. in the eye under study; • Subjects with subfoveal scar deformation, atrophy or hemorrhage in the studied eye; • Subjects in whom the CNV lesion in the eye under study contains more than 25% cicatricial deformity and / or atrophy; • Subjects with insufficient pupillary dilation or significant media opacity in the eye under study, including cataract, which may interfere with visual acuity or evaluation of the posterior segment; • Current vitreous hemorrhage in the eye under study; • History of rhegmatogenous retinal detachment or macular hole in the eye under study; • Subjects presenting choroidal neovascularization due to causes other than AMD, including ocular histoplasmosis syndrome, angioid striae, multifocal choroiditis, choroidal rupture or pathological myopia (spherical equivalent> 8 diopters or axial length> 25 mm); • Subjects undergoing intraocular surgery of the eye under study in the 12 weeks prior to the screening visit; • Subjects with previous posterior vitrectomy in the eye under study; • Subjects with known severe allergies to fluorescein used in angiography; • Subjects previously submitted to radiotherapy in the eye, head or neck; • Subjects with an intravitreal device or drug in the eye under study; • Subjects presenting any other process that, in the opinion of the researcher, could prevent the subject from completing the study (for example, dementia, mental disorder); • Subjects receiving prolonged treatment with systemic corticosteroids or other immunosuppressive therapy that may affect healing (eg, subjects who have received chemotherapy in the past 6 months) and immunosuppressed subjects (eg, HIV) • Subjects with a history of optic neuritis; • Subjects who have previously been diagnosed with diabetes mellitus type 1 or type 2 or who have signs on the retina indicative of it; • Previous intraocular surgery, except for cataract surgery. If the subject has undergone cataract surgery, the intervention must have been performed> 2 months before inclusion in the study; • Aphakia or lack of the posterior capsule in the eye under study. The opening of the posterior capsule is also excluded, unless it results from capsulotomy with yttrium-aluminum-garnet (YAG) associated with implant of intraocular lens in the posterior chamber (PCIOL); • Sensitivity or known allergy to Lucentis® (ranibizumab); • Current participation in a clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:With regard to the percentage of subjects who lose less than 15 optotypes in the visual acuity score with correction at 12 months compared to the baseline value, with a non-inferiority margin of 20%. The primary evaluation will be completed after 12 months Measure:non-inferiority of the Epi-Rad90 Ophthalmic System versus an active control Lucentis® Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Percentage of subjects recovering> 15 ETDRS optotypes Measure:Percentage of subjects recovering> 15 ETDRS optotypes Timepoints:After treatment ; Outcome name:Percentage of subjects recovering> O ETDRS optotypes Measure:Percentage of subjects recovering> O ETDRS optotypes Timepoints:After treatment ; Outcome name:Measurement of visual acuity Measure:Average variation of visual acuity according to ETDRS Timepoints:During treatment ; Outcome name:fluorescein angiography Measure:Variation in the total size of the lesion by fluorescein angiography Timepoints:During treatment ; Outcome name:fluorescein angiography Measure:Variation in the total size of CNV by fluorescein angiography Timepoints:During treatment | — |
Countries
Spain, United Kindgdom
Contacts
Public ContactRaul Salvador Cordero
PERUVIAN CLINICAL RESEARCH S.A.C
Outcome results
None listed