wet age-related macular degeneration MedDRA version: 14.1 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Name: ESBA1008, 10 mg/ml
Pharmaceutical Form: Solution for injection
INN or Proposed INN: not yet assigned
CAS Number: not assigned
Current Sponsor code: ESBA1008
Other descriptive name: anti-
Sponsors
Alcon Research Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must give written informed consent, be able to make the required study visits and follow instructions 2. Patient must be 50 years of age or older 3. Patient’s study eye must have: • primary subfoveal choroidal neovascularization (CNV) secondary to AMD, including predominantly classic, minimally classic or occult lesions • a lesion area 50% of the total lesion area. Total lesion area is defined as the area with angiographic evidence of neovascularization, associated contiguous areas of serous elevation of the RPE, elevated blocked fluorescence, and/or late staining • a new diagnosis of exudative AMD or evidence of recent disease progression within the last 3 months; if the CNV in the study eye is minimally classic or occult, evidence of recent disease progression is defined as having experienced a loss of at least 1 line of vision (5 ETDRS letters or one Snellen line), a change in lesion size of more than 2.54 mm2 (1 disc area) or the appearance of new blood in the lesion • subretinal blood, if present, must spare the fovea and must comprise 340 µm using a Spectralis SD-OCT (Heidelberg Engineering) imaging system • a best-corrected visual acuity (BCVA) ranging between 73 letters (20/40 Snellen equivalent) and 34 letters (20/200 Snellen equivalent), inclusive • clear ocular media and adequate pupil dilation to permit good quality photographic imaging 4. Patient’s fellow eye BCVA must be 34 letters (Snellen equivalent 20/200) or better 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 154
Exclusion criteria
Exclusion criteria: Shortened from protocol: 1. Patient received any previous treatment for AMD in the study eye 2. Any current or history of ocular disease in the study eye 3. Any evidence of fibrosis or scarring in the study eye 4. Any vitreous hemorrhage or history of rhegmatogenous retinal detachment in the study eye 5. Any previous surgery in the study eye (penetrating keranoplasty, vitrectomy, cataract surgery, LASIK or cataract removal in the last 3 months) 6. any active infection or inflammation in the study eye 7. uncontrolled glaucoma 8. aphakia in the study eye 9. use of topical or systemic cortecosteroids 10. history of a chronic medical condition that precludes study participation 11. laboratory abnormalities that would make the patient unsuitable for the study 12. severe hypersensitivity to any of the components of the IMPs that are being used in the study 13. Pregnant and breast-feeding women 14. participation in another clinical study within the last 30 days 15. CNV due to other reasons than AMD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of treatment following a single intravitreal administration of ESBA1008 compared to Lucentis in patients with exudative AMD;Secondary Objective: To assess the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared to Lucentis in patients with exudative AMD;Primary end point(s): Safety endpoints, such as AEs, changes in vital signs, laboratory abnormalities, anti-drug antibodies, changes in the eye conditions;Timepoint(s) of evaluation of this end point: Examined at all 13 visits throughout the study for 6 months. Note that not all safety parameters will be examined at each visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: Retina thickness measured by spectral domain optical coherence tomography (SD-OCT); retinal thickness is a known sign of AMD. Decrease of the thickness indicates improvement of AMD. Best corrected visual acuity (BCVA) by reading the ETDRS chart. visual acuity is the accepted clinical endpoint for AMD. Improvement of vision indicates improvement of AMD. ;Timepoint(s) of evaluation of this end point: Examined at all 13 visits throughout the study for 6 months. An analysis will be performed 1 month after the drug administration. | — |
Countries
Australia, Austria, Germany, Israel, United States
Contacts
Public ContactInez Carels, Regulatory Affairs
n.v. Alcon Couvreur s.a.
Outcome results
None listed