Choroidal neovascularization secondary to angioid streaks . MedDRA version: 17.1 Level: LLT Classification code 10060837 Term: Choroidal neovascularization System Organ Class: 100000004853
Conditions
Interventions
Trade Name: Eylea 40 mg/ml solution for injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AFLIBERCEPT
CAS Number: 862111-32-8
Other descriptive name: AFLIBERCEPT
Concentration
Sponsors
IRCCS Ospedale San Raffaele U.O. Oculistica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Men and women = 18 years of age • Presence of CNV associated with angioid streaks, naïve or previously treated with exudative manifestations involving the fovea • Best-corrected visual acuity (BCVA) between 20/400 and 20/25. • Signed Informed Consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Prior antiangiogenic treatment within 30 days prior the Screening visit • Hypersensitivity to the active substance or to any of the excipients • ocular or periocular infection suspected or in progress • severe intraocular inflammation in progress • Inability to document the lesion with retinography, retinal fluorescein angiography (FAG), autofluorescence, optical coherence tomography (OCT) for media opacities, allergy to dyes, lack of venous access. • Any other medical condition of the eye that can irreversibly affect the visual acuity in the study eye, including amblyopia, ischemic optic neuropathy, clinically significant diabetic macular edema, severe nonproliferative diabetic retinopathy • Women who are pregnant or breastfeeding. Women of childbearing age will be excluded unless they make use of contraceptive during treatment and for at least 3 months after the last injection of intravitreal Aflibercept
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety of intravitreal Aflibercept in patients with choroidal neovascularization in angioid streaks;Secondary Objective: Not Applicable;Primary end point(s): 1. Mean average change in BCVA from baseline to month 12 2. Percentage of eyes with stabilization of BCVA within 15 letters at month 12;Timepoint(s) of evaluation of this end point: 1. Month 12 2. Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of eyes gaining at least 15 letters in BCVA from baseline to month 12 2. Changes in central macular thickness as assessed by OCT from baseline to month 12 3. Changes in CNV lesion from baseline to month 12 4. Total number of intravitreal injections performed up to 12 months 5. Frequency and type of Adverse Events ophthalmological and systemic up to 18 months;Timepoint(s) of evaluation of this end point: 1. Month 12 2. Month 12 3. Month 12 4. Month 12 5. Month 18 | — |
Countries
Italy
Contacts
Public ContactU.O. Clinica Oculistica
IRCCS Ospedale San Raffaele
Outcome results
None listed