A Multicenter, Masked, Randomized, Sham-controlled, Paired-eye Comparison, 12-Month (Plus 12-Month Extension) Study to Evaluate the Safety and Effects on Retinal Structure and Visual Function of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS) Applicator System in Patients with Geographic Atrophy from Age-related Macular Degeneratio

• Conditions: Geographic Atrophy from Age-related Macular Degeneration

• Registration Number: EUCTR2008-001487-37-DE
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-23
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Participant must have GA present in both eyes that is attributed to AMD. GA may be single or multi-focal and is defined as well-defined, circular areas of partial or complete depigmentation of the retinal pigment epithelium (RPE), typically with more readily visible underlying choroidal blood vessels. At the screening visit, at least one site of GA must be at least 0.75 disc area (DA) (2.02 mm2), some of which falls within a 1500 micron radius of the foveal center, and = 12 DA (32.28 mm2) in both eyes. All sites of macular GA must be visible within 30 degree images centered on the fovea (field 2 macular photographs) without extension to the margin of these photographs. When measuring peripapillary atrophy, regardless of whether it is contiguous with any other macular areas of atrophy, draw a vertical line through the center of the optic nerve and include any atrophy on the temporal side of the vertical line.
2. At the screening visit, the ocular media must be clear enough for good quality photographs in both eyes as determined by the investigator. Areas of GA identified on clinical examination should be visible in the fundus photographs
3. In the treated eye, best-corrected visual acuity (BCVA) letter score between 70 (approximately 20/40 Snellen equivalent) and 35 (approximately 20/200 Snellen equivalent) inclusive as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the screening visit
4. In the fellow eye, BCVA letter score of 25 (Snellen equivalent 20/320) or better as measured by the ETDRS method at the screening visit
5. Man or woman, 50 years of age or older
6. Women of childbearing potential must have a negative urine pregnancy test at the screening visit and prior to treatment on Day 1. A woman is considered of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries
7. Written informed consent has been obtained
8. Ability to understand the informed consent and willingness to follow study instructions and likely to complete all required visits and procedures
9. Written Authorization for Use and Release of Health and Research Study Information (US sites only) has been obtained
10. Written Data Protection Consent (European sites only) has been obtained
11. Written documentation has been obtained in accordance with the relevant country and local privacy requirements, where applicable
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

1. Known allergy to brimonidine tartrate or any component of the delivery vehicle or diagnostic agents used during the study (eg, fluorescein, dilation drops), or persons for whom the administration of fluorescein injection is contra-indicated according to national approved prescribing information for fluorescein
2. Uncontrolled systemic disease
3. Women who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
4. Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to the screening visit
5. Patient has a condition or is in a situation that in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study
6. Any injectable intravitreal treatment to either eye or intravitreal implant of any type in either eye within 6 months prior to the screening visit, between the screening visit and Day 1, or anticipated use during the study
7. Periocular injections of corticosteroids to either eye within 4 months prior to the screening visit or anticipated use during the study
8. Contraindication to pupil dilation in either eye
9. Use of brimonidine, apraclonidine, or any other topical alpha-2 agonist in either eye within 2 weeks prior to the screening visit or anticipated use during the study
10. Use of systemic alpha-2 antagonists (eg, phentolamine, phenoxybenzamine, yohimbine, idazoxan) or systemic alpha-2 agonists (eg, clonidine) within 2 weeks prior to the screening visit or anticipated use during the study
11. Any condition (including inability to read visual acuity, contrast sensitivity or reading speed charts or a language barrier) that precludes the patient’s ability to comply with study requirements, including completion of the study
12. Any infective condition in either eye
13. History or evidence of choroidal neovascularization in either eye based on fluorescein angiogram performed at the screening visit
14. Any ocular condition in either eye other than AMD that may progress during the course of the study and could affect central vision, or other ocular conditions that may be a confounding factor in this study
15. Evidence of RPE abnormalities consistent with a pattern dystrophy or pseudovitelliform lesion in either eye
16. Evidence of vitreo-retinal traction maculopathy in either eye
17. History of laser or photodynamic therapy (PDT) to the macula of either eye
18. Any intraocular surgery or laser in either eye within 6 months prior to Day 1
19. GA in either eye secondary to any condition other than AMD, or secondary to drugs (eg, antimalarials)

Study & Design

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