Study of the safety and efficacy of a treatment for Patients with macular degeneration using a Device for inter vitreol administartio

Phase 1

• Conditions: Patients of either sex, 50 years of age or older, with a diagnosis of Choroidal Neovascularization CNV due to Age-Related Macular Degeneration AMD in the study eye; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2015-003816-19-LV
• Lead Sponsor: ForSight VISION4, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-27
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Males and females 50 years of age or older
2.Capable of understanding the requirements of the study, willing to follow study instructions, to provide written informed consent to participate, and who agree to comply with all study requirements, including the required study follow-up visits.
3.Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography for which anti-VEGF intraocular injection is indicated (> 25% active disease with < 75% of the lesion size representing scar, pigment epithelial detachment, blood or atrophy).
4.Intravitreal treatment of study eye with VEGF-inhibitor(s) ranibizumab, bevacizumab, or Eyelea (aflibercept) within the past 12 months, with demonstrated response (decrease in central subfield foveal thickness (CSFT) of 50 µm or greater from prior measurement).
5.Increased retinal thickness defined as central subfield foveal thickness (CSFT) in excess of + 2 standard deviations of normal (315 microns as measured by Spectralis OCT).
6.CSFT must measure 50 µm greater than the lowest CSFT following the anti-VEGF injection to which responsiveness had been confirmed within the preceding 6 months.
7.Best corrected visual acuity between 20/80 and counting fingers in the eye to be treated
8.Best corrected visual acuity in fellow eye = study eye
9.Sufficient media clarity to allow for good visibility of macular area on biomicroscopy
If both eyes of an individual qualify, the eye with the worse BCVA will be selected as the study eye. If both eyes have the same BCVA, the study eye will be the eye with the worse macular edema.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Prior vitrectomy in the study eye
2.Any periocular/intraocular injections in the study eye in the past 2 months.
3.Any ophthalmic surgery performed on the study eye within the past 1 month
4.Recent or current evidence of ocular infection or inflammation in either eye.

5.Use of anticoagulant, non-inclusive of non-steroidal anti-inflammatory agents (NSAID) or aspirin, within 14 days of enrollment
6.Uncontrolled glaucoma defined as IOP greater than 25 mm Hg.
7.Hypotony (defined as IOP of 5 mm Hg or less)
8.Uncontrolled hypertension, systolic BP > 155 mm Hg.
9.Uncontrolled systemic disease (eg, diabetes, hypertension, etc.) that in the opinion of the Investigator could confound the study outcomes or prevent the patient from completing the study
10.Participation in any study involving an investigational drug within the past 30 calendar days, or ongoing participation in a study with an investigational product.
11.Known intolerance or hypersensitivity to any component of the investigational drug or ranibizumab formulations to be used (eg, polyvinylpyrrolidone [PVP], cyclodextrins), components of the drug delivery device (polymethyl methacrylate [PMMA], titanium, silicone), or to topical anesthetics, mydriatics or antibiotics.
12.Females who are pregnant or nursing and women of childbearing potential who are not using adequate contraceptive precautions (eg, intrauterine device, oral contraceptives, barrier method or other contraception deemed adequate by the Investigator)
13.Have angioid streaks, presumed ocular hisoplasmosis syndrome, myopia (> 8 diopters) or CNV secondary to other causes than AMD
14.Any additional ocular disease, which may have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, or diabetic retinopathy
15.Inability to obtain photographs, fluorescein angiography (FA) or OCT to document CNV, eg, due to media opacity, allergy to fluorescein dye or lack of venous access
16.Any condition that, in the opinion of the investigator, would jeopardize the safety of the subject

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified