Geographic Atrophy from Age-related Macular Degeneration
Conditions
Sponsors
Allergan Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of the Brimo PS DDS Applicator System (200 µg and 400 µg brimonidine tartrate) in patients with geographic atrophy (GA) from age-related macular degeneration (AMD) To evaluate the effects of the Brimo PS DDS Applicator System (200 µg and 400 µg brimonidine tartrate) on retinal structure in patients with GA from AMD To evaluate the effects of the Brimo PS DDS Applicator System (200 µg and 400 µg brimonidine tartrate) on visual function in patients with GA from AMD;Secondary Objective: ;Primary end point(s): Efficacy Measures: Primary: change in size of geographic atrophy from baseline to Month 12 based on stereoscopic color fundus photography and/or fluorescein angiography as measured by the reading center Secondary: visual acuity (BCVA by ETDRS), contrast sensitivity, reading speed, National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), Vision Preference Value Scales and Enthusiasm Questionnaire Other: Optical coherence tomography (OCT), multifocal electroretinography (mfERG), fundus autofluorescence (FAF), infrared images and red-free images will be collected optionally at selected sites (Stage 2 patients only). Pharmacokinetics: A single blood sample for determination of plasma brimonidine concentration will be collected on Day 1 before the treatment procedure, on Day 7, and at Months 1, 3 and 6. The samples will be collected from all patients who consent to this procedure at all clinical sites qualified for the collection and handling of pharmacokinetic Samples. Plasma brimonidine concentrations will be determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method with an LLOQ of 2 pg/mL. Safety Measures: Adverse events Ocular: biomicroscopy, indirect ophthalmoscopy, intraocular pressure (IOP), visual acuity (BCVA by ETDRS), and DDS residual assessment (in the treated eye) Non-ocular: blood pressure (systolic/diastolic), pulse rate, respiration rate, and urine preg | — |
Countries
Germany, Italy, Portugal, United Kingdom
Outcome results
None listed