Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™...
Eye DiseasesMacular Degeneration4 moreThe purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with and without Lucentis™ in patients with wet age related macular degeneration (AMD). This study will be conducted in two parts: Part 1 will comprise an open label, sequential dose escalation and Part 2 a randomized dose expansion. OPT-302 is a soluble form of VEGFR-3 comprising the extracellular domains 1-3 of human vascular endothelial growth factor receptor (VEGFR)-3 and the Fc fragment of human IgG1. It functions by binding and neutralizing the activity of vascular endothelial growth factor (VEGF)-C and VEGF-D on endogenous VEGFR-2 and VEGFR-3. VEGF-C and VEGF-D promote blood vessel development (angiogenesis) by binding and activating VEGFR-2 and VEGFR-3. VEGF-C is also a potent inducer of vascular permeability or leakage. Angiogenesis and vascular leakage are key hallmarks of wet AMD. Approved therapies for wet AMD include Eylea™ and Lucentis™ which block the activity of VEGF-A, but not VEGF-C or VEGF-D which are alternate members of the same family of molecules. VEGF-C and VEGF-D can stimulate blood vessel growth and leakage through the same pathway as VEGF-A (via VEGFR-2), as well as through pathways that are independent of VEGF-A (via VEGFR-3). Published studies have also indicated that VEGF-C and VEGF-D play an important role in mediating resistance to therapies that block VEGF-A such as Lucentis™ and Eylea™. Combination therapy with OPT-302 an anti-VEGF-A agent provides a more complete blockade of the VEGF family. This strategy targets functional redundancy in the VEGF pathway and mechanisms of 'resistance' or sub-response to VEGF-A inhibition.
Cyclosporin Implant to Treat Uveitis
Eye DiseaseInflammation1 moreThis study will evaluate the safety and effectiveness of a sustained-release cyclosporin implant to treat uveitis, a sight-threatening eye inflammation caused by an immune system abnormality. Previous studies in humans have shown that, taken by mouth, the drug cyclosporin is effective in treating chronic uveitis. Uveitis may require long-term treatment with potent immune-suppressing drugs, such as cyclosporin, cyclophosphamide, methotrexate, azathioprine or steroids. Taken systemically (by mouth or injection), however, these drugs can do serious damage to the kidneys, liver or lungs, and can raise blood pressure and lower blood cell counts. Because of this, some patients cannot or will not use these medicines. This small pilot study will evaluate the safety, and to some extent effectiveness, of cyclosporin delivered directly into the eye, to try to prevent harmful side effects. In animal studies, sustained-release cyclosporin implants did not cause the severe side effects seen with systemic use of the drug. Some animals developed opacity of the lens and slowed retinal responses, both of which reversed when the drug was stopped. Earlier animal studies of cyclosporin injected directly into the eye reduced inflammation that had been produced experimentally. Patients with uveitis who have active inflammation and poor vision are eligible to participate in this study. Patients will be randomly assigned to one of two treatment groups. One group will receive a 1-mg implant that releases 0.8 micrograms of drug each day; the second group will receive a 2-mg implant that delivers 1.4 micrograms of drug a day. Before surgery, patients will have a medical history, basic physical examination, and complete eye examination, including special tests called electroretinogram and fluorescein angiography. An electroretinogram measures the electrical responses generated in the retina in the back of the eye. Fluorescein angiography uses a special camera to photograph the retina, showing the condition of the blood vessels in the eye. The surgical procedure to place the implant takes about 1.5 hours and may be done under either local or general anesthesia. Patients will stay in the hospital overnight. After discharge from the hospital, they will return for follow-up visits 1 and 2 weeks after surgery, then once a month for 6 months, and then every 3 months until the implant is depleted of drug or removed. During these follow-up visits, eye examinations will be repeated to evaluate the effects of the implant on the eye. Repeat blood tests will measure the amount of cyclosporin in the blood and the drug's effect on the kidneys. When the implant runs out of drug (between 2 and 3 years), it may be removed or left in place.
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of OC-01 in Adult Chinese With Dry Eye...
Dry Eye DiseaseThe objective of this study is to evaluate the pharmacokinetics (PK) in adult Chinese subjects with dry eye disease (DED)1 after bilateral nasal spray administration of OC-01 (varenicline solution) Nasal Spray at a concentration of 0.6 mg/mL.
Single Superior ILM/ERM Flap for the FTMH.
OphthalmopathyIn this study, the investigators will make the only upper flap either from the internal limiting membrane or from the epiretinal membrane to cover the full thickness macular hole.
Study of Brimonidine Tartrate Nanoemulsion Eye Drop Solution in the Treatment of Dry Eye Disease...
Dry EyeThis study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the treatment of Dry Eye Disease (DED). Half of participants will receive Brimonidine and half will receive ophthalmic buffered saline (placebo).
Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With...
Age-Related Macular DegenerationMacular Degeneration4 moreThe purpose of this study was to collect ECG data after a single IVT injection of brolucizumab 6 mg in patients with neovascular age-related macular degeneration (nAMD).
Evaluation of Ocular Comfort With ISTA Tears vs Systane
Dry Eye DiseaseTo assess the comfort preference of ISTA Tears vs Systane in patients with dry eye disease (DED)
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase
Dry Eye DiseaseOcular ComfortTo compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease
Treatment of Pseudovitellium Detachment With Open-Label Anecortave Acetate Sterile Suspension (15...
Pseudovitellium DetachmentEye DiseasesThe purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control pseudovitelliform detachment.
Femtosecond Small Incision Lenticular Extraction in Comparison to Femtosecond Laser Insitu Keratomileusis...
Dry Eye DiseaseComparison of femtosecond small incision lenticule extraction (FS-SMILE) versus Femtosecond laser Insitu Keratomileusis (FS-LASIK) regarding dry eye disease (DED) and corneal sensitivity (CS) after those refractive surgeries.