Safety, Tolerability and Efficacy Study of ESBA1008 versus LUCENTIS® for the Treatment of Exudative Age-Related Macular Degeneratio

Completed

Conditions: Exudative Age-Related Macular Degeneration
10047060

Registration Number: NL-OMON35753

Lead Sponsor: Alcon Laboratories

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

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 1 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
* retinal edema as measured by 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

Exclusion Criteria

1. Patient has received any previously administered therapy, approved or investigational, for exudative AMD in the study eye
2. Any current or history of ocular disease in the study eye that, in the opinion of the Investigator, may confound assessment of the macula or affect central vision, other than exudative AMD (for example: vein occlusion, diabetic retinopathy, uveitis, angioid streaks, ocular histoplasmosis, pathological myopia, retinal detachment, epiretinal membrane, macular hole)
3. Any evidence in the study eye of fibrosis or scarring within the lesion
4. Any vitreous hemorrhage or a history of rhegmatogenous retinal detachment in the study eye
5. History or evidence of the following surgery in the study eye:
* penetrating keratoplasty or vitrectomy
* cataract surgery or Lasik within the last 3 months
* OR expected to have cataract removal surgery during the study
6. Any active ocular infection or inflammation in either eye (such as: blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis)
7. A history or medical diagnosis of uncontrolled glaucoma (defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication), advanced glaucoma resulting in a cup/disc ratio > 0.8 in the study eye or glaucoma filtration surgery in the study eye
8. Aphakia in the study eye or violation of the posterior capsule in the study eye unless it occurred as a result of a YAG laser posterior capsulotomy in association with prior, posterior intraocular lens implantation
9. Current use or history of chronic therapy with systemic or topical ocular corticosteroids (defined as multiple doses taken daily for 3 or more consecutive days at any time within 6 months prior to enrollment)
10. History of a medical condition (disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that, in the opinion of the Investigator, would preclude scheduled study visits, completion of the study or a safe administration of study medication (eg, unstable or progressive cardiovascular, pulmonary, Parkinson's disease, liver or renal disease, cancer or dementia)
11. Any screening laboratory result (hematology, serum chemistry or urinalysis) that, in the opinion of the Investigator, would make the patient unsuitable for study participation; any screening liver function test value [AST (SGOT), ALT (SPGT), alkaline phosphatase, GGT, total bilirubin, direct bilirubin, indirect bilirubin, and LDH] that is more than twice the upper limit of normal
12. History of severe or serious hypersensitivity to any component of the test article, control article or clinically relevant sensitivity to fluorescein dye, as assessed by the Investigator
13. Women of childbearing potential, ie, premenopausal or less than 2 years postmenopausal, who are lactating, or who are pregnant as determined by serum pregnancy test at Visit 1.
Women should plan not to become pregnant during the course of the study.
Women of childbearing potential must agree to use adequate birth control methods for the duration of the study defined as:
* Hormonal: oral, implantable, topical, or injectable contraceptives
* Mechanical: IUD, spermicide in conjunction with a barrier such as condom or diaphragm
* Surgical: sterilization of self or partner
* Abstinence: If subjects intend to become sexually active, they must agree to use one of the birth control methods li

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety endpoints, such as AEs, changes in vital signs, laboratory<br /><br>abnormalities, anti-drug antibodies, changes in the eye conditions. This will<br /><br>be examined at all 13 visits throughout the study for 6 months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Retina thickness measured by spectral domain optical coherence tomography<br /><br>(SD-OCT); retinal thickness is a known sign of AMD. Decrease of the thickness<br /><br>indicates improvement of AMD.<br /><br><br /><br>Best corrected visual acuity (BCVA) by reading the ETDRS chart. visual acuity<br /><br>is the accepted clinical endpoint for AMD. Improvement of vision<br /><br>indicates improvement of AMD.<br /><br><br /><br>This will be examined at all 13 visits throughout the study for 6 months.</p><br>