Retinal Physician

JAN-FEB 2017

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R E T I N A L P H Y S I C I A N | N O V E M B E R / D E C E M B E R 2 0 1 6 59 59 CLINICAL TRIAL UPDATE more well-defined and often circular patches of partial or complete depigmentation of the RPE, typically with exposure of underlying choroidal blood vessels. Even if much of the RPE appears to be preserved and large choroidal vessels are not visible, a round patch of RPE partial depigmentation may be classified as early GA. The GA in the study eye must be able to be photographed in its entirety, and it must not be contiguous with any areas of peripapillary atrophy, which can complicate area measurements Information: Study: An Open-Label, Phase 1 Clinical Study to Evaluate the Safety and Tolerability of Subcutaneous Elamipretide in Subjects With Intermediate Age-Related Macular Degeneration Sponsor: Stealth BioTherapeutics Purpose: To test 40 mg of elamipretide administered as a once daily 1.0 mL subcutaneous injection for 12 weeks Design: Safety, Single Group, Open Label Number of Patients: 40 Inclusion Criteria: No evidence of choroidal neovascularization (active or prior history) in the study eye; geographic atrophy may be multifocal, but the cumulative GA lesion size must be: ≥ 1.27 mm2 (approximately ≥ 0.5 DA) and ≤ 10.16 mm2 (approximately ≤ 4 DA); must reside completely within the FAF imaging field (field 2 to 30-degree image centered on the fovea); presence of measurable hyperautofluorescence adjacent to the discrete foci of GA. OR Intermediate AMD - high-risk drusen without GA disease group Exclusion Criteria: Age-related macular degeneration with any evidence of central GA (i.e., involving the fovea); atrophic retinal disease because of causes other than AMD; presence or diagnosis of exudative AMD or choroidal neovascularization in the study eye; history of diabetic retinopathy (a history of diabetes mellitus without retinopathy is not a criterion for exclusion); presence of vitreous hemorrhage; history of retinal detachment or macular hole (stage 3 or 4) in the study eye; presence of macular pucker Information: kit.oldham-creamer@stealthbt. com Double-blind Number of Patients: 255 Inclusion Criteria: Confirmed diagnosis of geographic atrophy (GA) secondary to age- related macular degeneration (AMD) confirmed within 28 days prior to initial randomization by the central reading center; study eyes will have a best corrected visual acuity (BCVA) of 20/80 to 20/800 [Early Treatment Diabetic Retinopathy Study (ETDRS) log of the minimum angle of resolution (logMAR) value 0.6-1.6]. BCVA in the treatment eye must be worse than the BCVA in the fellow eye at screening Exclusion Criteria: Participant has a history of neovascular ("wet") AMD in the treatment eye, including any evidence of retinal pigment epithelium rips or evidence of subretinal or choroidal neovascularization. History or evidence of neovascular AMD in the fellow eye is allowed, if anti-vascular endothelial growth factor (VEGF) therapy has not been required for at least 8 weeks prior to Screening; geographic atrophy secondary to any causes other than AMD in either eye Information: Home.aspx?CR106814 Study: METforMIN: Metformin for the Minimization of Geographic Atrophy Progression in Patients With AMD Sponsor: University of California, San Francisco Purpose: To determine whether metformin, an FDA-approved drug for the treatment of type II diabetes, is a safe and effective treatment to decrease the progression of geographic atrophy in non-diabetic patients with age- related macular degeneration Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-blind Number of Patients: 100 Inclusion Criteria: Subject must have evidence of advanced dry AMD, defined by the characteristic presence of drusen and/or pigmentary changes, as well as geographic atrophy; subject must have clear ocular media and adequate pupillary dilation; study eye must have best corrected visual acuity (BCVA) of 20/20 to 20/400 Exclusion Criteria: Subjects with insufficient baseline size of geographic atrophy, less than 1.25 mm2 (0.5 Macular Photocoagulation Study Disc Areas). GA is defined as one or Information: Study: PRO-CON: IAI Versus Sham as Prophylaxis Against Conversion to Neovascular AMD Sponsor: Jeffrey S. Heier, MD/Regeneron Purpose: To evaluate intravitreal aflibercept injection (IAI) versus sham as prophylaxis against conversion to neovascular age-related macular degeneration (AMD) in "high-risk" subjects Design: Randomized, Parallel Assignment, Single-blind Number of Patients: 128 Inclusion Criteria: Study eye must have a diagnosis of non-exudative age-related degeneration characterized by the presence of many intermediate sized drusen, 1 or more large drusen, and/or hyperpigmentary changes. Fellow (non-study) eye must have CNV lesion (i.e., leakage on fluorescein angiography and/or subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age- related macular degeneration OR history of CNV lesion secondary to age-related macular degeneration, as confirmed by current or past treatment or current or past diagnostic imaging Exclusion Criteria: Evidence of neovascular AMD in the study eye at time of enrollment or anytime in the past. The reading center must confirm that there is no evidence of neovascular AMD in the study eye prior to enrollment; serous PED of any size in the study eye, as determined by the reading center; previous treatment with verteporfin PDT, anti- VEGF therapy, laser, external beam radiation or other AMD therapy in the study eye Information: Study: PRELUDE: A Study to Evaluate the Safety and Clinical Response of Subretinal Administration of CNTO 2476 in Participants With Geographic Atrophy Sponsor: Janssen Research & Development, LLC Purpose: To evaluate the safety and performance profile of a modified surgical procedure and custom delivery devices and also to assess the effects on visual acuity of a single subretinal administration of CNTO 2476 Design: Randomized, Parallel Assignment, R E T I N A L P H Y S I C I A N . C O M | J A N U A R Y / F E B R U A R Y 2 0 1 7

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