Age-Related Macular Degeneration (Wet & Dry)

July 28, 2016

Age-Related Macular Degeneration or AMD is the leading cause of blindness in patients 60 and older due to abnormal blood vessel growth under the retina. The goal of new therapies is to preserve and improve vision and to extend treatment intervals. We place high priority on a patient’s quality of life and ability to function in daily activities.

To demonstrate how drastically medical advances impact our specialty field, consider this: Less than 10 years ago, we were only able to help a small percentage of patients treated for Wet/Dry AMD. Today, thanks to advances in treatment, we see a (significant) improvement or stabilization in 95 percent of patients we treat for this condition.

Current clinical trials for Wet/Dry AMD:

Alcon LHA510-2210:

A Phase 2, randomized, double masked, vehicle-controlled, proof of concept study for topically delivered LHA510 as a maintenance therapy in patients with Wet AMD.

 Alcon RTH258-C001:

A Phase 3, two year randomized, double-masked, 3 arm study comparing the efficacy and safety of RTH258 vs Aflibercept in subjects with Wet AMD

Allergan 190432-038 (Beacon):

A Phase 2b, multicenter, randomized, double masked, sham treatment, controlled Safety and Efficacy of Brimonidine Posterior Segment drug delivery system in patients with Geographic Atrophy secondary to AMD

Allergan 005:

A Phase 3, Safety and Efficacy of Abicipar Pegol (AGN-150998) in Patients with Neovascular Age-Related Macular Degeneration

Genentech GX28198:

A multicenter, open-label extension study to evaluate the long-term safety and tolerability of FCFD4514S in patients with Geographic Atrophy.

Genentech GX29639:

A multicenter, prospective epidemiologic study of the progression of Geographic Atrophy secondary to AMD

Genentech GX29455:

A Phase 2, Multicenter, Randomized, Single-Masked, Sham injection controlled exposure-response study of Lampalizumab intravitreal injections administered every two weeks or every four weeks to patients with Geography Atrophy.

Genentech-Chroma GX29176:

A Phase 3, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to assess the efficacy and safety of Lampalizumab administered intravitreal to patients with Geographic Atrophy Secondary to Age-Related Macular Degeneration.

Opthotech OPH1004:

A Phase 3, randomized, double-masked, controlled trial to establish the safety and efficacy of intravitreous administration of Fovista (Anti PDGF-B Pegylated Aptamer) Administered in combination with either Avastin or Eylea compared to Avastin or Eylea monotherapy in subjects with subfoveal neovascular age-related macular degeneration

Opthea OPT-302:

A Phase I, Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 in Combination with Ranibizumab in Subjects with Wet Age-Related Macular Degeneration. This Study is Projected to Last 3.5 Months from Enrollment to Completion for Each Study Participant.

Vision Care Implantable Miniature Telescope IMT-PAS-01:

A Phase 4, Prospective, Multicenter Post-Approval Study (PAS) of VisionCare’s Implantable Miniature Telescope (By Dr. Isaac Lipshitz) in Patients with Bilateral Severe to Profound Central Vision Impairment Associated with End-Stage Age-Related Macular Degeneration. This Study is Projected to Last 5 Years from Enrollment to Completion for Each Study Participant to Evaluate the Long Term Safety Associated with use of the Intraocular Telescope.

Acucela 4429-202:

A Phase 2b/3, multicenter, randomized, double masked, dose ranging study comparing the efficacy and safety of Emixustat Hydrochloride (ACU 4429) with placebo for the treatment of Geographic Atrophy associated with Dry Age-Related Macular Degeneration.                                                                       *This is closed for enrollment

Past clinical trials for Wet AMD:

Regeneron View 1

Double masked study of efficacy and safety of intravitreal VEGF Trap-Eye in subjects with wet AMD. Patients who complete Regeneron View 1 then become candidates for a subsequent study, Regeneron Clearit.

Regeneron Clearit

lucentisdiagram 300x225 Age Related Macular Degeneration (Wet & Dry)

Investigation of efficacy and safety of intravitreal VEGF Trap-Eye in wet AMD.

VEGF Trap is a fusion protein designed to bind proteins involved in abnormal blood vessel growth in wet AMD. These studies compare treatment with VEGF Trap-Eye and Lucentis, an anti-angiogenic agent approved for use in wet AMD. The studies compare treatment with VegF Trap-EYE and Lucentis versus Lucentis alone. Lucentis is currently the only FDA-approved treatment for Wet AMD.

Genentech HARBOR

An active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0mg Ranibizumab in patients with wet AMD. This study compares the currently approved dose of Lucentis with one that is four times the concentration.