Safety and efficacy study with ESBA1008 versus Lucentis for the treatment of exudative age-related macular degeneratio

Conditions: wet age-related macular degeneration
MedDRA version: 14.1Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2011-000536-28-AT

Lead Sponsor: Alcon Research Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 194

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 < 30 mm2 (12 disc areas) of any lesion type (predominantly classic, minimally classic or occult)
• total area of CNV (including both classic and occult components) must comprise > 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 <50% of the total lesion
• evidence of subretinal fluid or retinal cystic changes with a central subfield thickness (CSF) of > 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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Efficacy endpoints:<br><br>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.<br><br>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.<br>An analysis will be performed 1 month after the drug administration.

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