The Safety and Efficacy of AL-8309B Ophtalmic Solution for the treatment of Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) - Geographic Atrophy Treatment Evaluation (GATE)

• Conditions: Geographic Atrophy secondary to AMD; MedDRA version: 12.0Level: LLTClassification code 10063947Term: Geographic atrophy

• Registration Number: EUCTR2008-007705-37-IT
• Lead Sponsor: Alcon Research, Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 15 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

Patient must be willing to give written informed consent, make the required study visits, and follow instructions. Patient must be 55 years of age or older. Patient must state the ability to administer eye drops or have a caretaker to administer the eye drops. The study eye must have: A well-demarcated area of atrophy (at least one lesion if multifocal) secondary to age-related macular degeneration equal to or larger than 1.25 mm2 [0.5 Disc Areas (DA)] with a total lesion size less than or equal to 20 mm2 [8 (DA)]. No history or evidence of CNV A best corrected visual acuity (BCVA) of 35 letters (20/200 Snellen equivalent) or better. Clear ocular media and adequate pupillary dilation to permit good quality photographic imaging. There are no inclusion criteria for the fellow eye.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine (hCG > 20 mIU/ml) or serum pregnancy test (hCG > 5 mIU/ml). Pre-menopausal women of child-bearing potential not using adequate contraception. Women of child-bearing potential are defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy OR are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation. Note: All females of childbearing potential must consent to a urine or serum pregnancy test upon entering and exiting the study. Note: Instruct females of childbearing potential to immediately inform the investigator if they become pregnant during the study. Should this occur, the investigator shall immediately contact the Sponsor as detailed in Section 9.3. Ocular disease in the study eye that in the opinion of the Investigator may confound assessment of the retina or affect central vision, other than non-exudative AMD [e.g., branch retinal vein occlusion (BCVO), diabetic retinopathy, uveitis]. History of cataract surgery in either eye within the past three (3) months of screening (Visit 1). History or evidence of serious ocular trauma or intraocular surgery (e.g. Lasik, keratoplasty) in either eye within the past six (6) months of screening (Visit 1). Current or previous use of serotonin receptor agonists, selective serotonin reuptake inhibitors (SSRIs), selective serotonin/epinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), and triptans within 30 days of screening (Visit 1). Evidence of significant uncontrolled comorbidity or condition with a limited survival prognosis (e.g., cancer, severe/unstable cardiovascular disease) that would make participation in the trial or adherence to the study schedule difficult or unlikely. History of severe or serious hypersensitivity to any components of the test articles (see Section 6.1.1. Study Medication). Known medical history of allergy or sensitivity to fluorescein dye that is clinically relevant in the investigator`s opinion. Participation in an investigational drug or device study within 30 days of screening (Visit 1). Additionally, the Medical Monitor may declare any patient ineligible to particip

Study & Design

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