CRMD’s research program is one of the largest in the country for a community-based practice and rivals those of some of the largest academic medical centers.
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Clinical trials used in drug development are sometimes described by phase. These phases are defined By the Food and Drug Administration – each phase is designed to answer a separate research question.
- Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
- Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
- Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
Wet Age-Related Macular Degeneration
Opthea– A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD). Phase 2.
ClinicalTrials.gov Identifier: NCT03345082
Allergan – The objective of this study is to evaluate abicipar for safety and treatment effect in patients with neovascular Age-related Macular Degeneration (AMD).
Clinicaltrials.gov Identifier: NCT03539549
Dry Age Related Macular Degeneration
Opthotech 2003 – A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura® (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02686658
Aldeyra ADX-102 – A Phase 3, Randomized, Double-masked, Vehicle-controlled Trial to Evaluate the Safety and Efficacy of ADX-102 Ophthalmic Solution in Subjects With Non-infectious Anterior-uveitis.
ClinicalTrials.gov Identifier: NCT03131154
Retinal Vein Occlusion
Clearside Topaz – This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.
ClinicalTrials.gov Identifier: NCT03203447
Diabetic Macular Edema
Kalvista – A randomized sham-controlled double-masked phase 2a study of the efficacy, safety and tolerability of the intravitreal plasma kallikrein inhibitor, KVD001, in subjects with center-involving diabetic macular edema who have had prior anti-vascular endothelial growth factor treatment.
ClinicalTrials.gov identifier: NCT03466099
CLOSED TO ENROLLMENT
Peachtree CLS1001-301 – A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis
ClinicalTrials.gov identifier: NCT02595398
Regenron 1411 – A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
ClinicalTrials.gov Identifier: NCT02718326
Novartis LKA651 – A Randomized, Single-masked, Sham-control, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema From Diabetic Macular Edema (DME), Neovascular Age-related Macular Degeneration (AMD), or Retinal Vein Occlusions (RVO)
ClinicalTrials.gov identifier: NCT02867735
Regeneron 1517 – A Randomized, Double-Masked, Active-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal REGN910-3 in Patients With Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov Identifier: NCT02713204
Allergan 006 Sequoia – This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.
ClinicalTrials.gov Identifier: NCT02462486
Tyrogenics – A Phase 1 Open-label, Dose Escalation Clinical Trial to Evaluate the Safety and Preliminary Biologic Activity/Efficacy of the VEGFR/PDGFR Inhibitor X-82 Administered Per Os in Subjects With Neovascular Age-related Macular Degeneration (AMD)
ClinicalTrials.gov Identifier: NCT01674569
Sci Fluor SFO166-C-002 – Phase i/ii randomized, double-masked, multicenter clinical trial designed to evaluate the safety and exploratory efficacy of sf0166 topical ophthalmic solution in the treatment of neovascular age-related macular degeneration (AMD)
ClinicalTrials.gov Identifier: NCT02914639
SciFluor SFO166-C-001 – A Phase I/II Randomized, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of SF0166 Topical Ophthalmic Solution in the Treatment of Diabetic Macular Edema (DME)
ClinicalTrials.gov identifier: NCT02914613
Clearside Sapphie CLS 1003-301 – A randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion.
ClinicalTrials.gov Identifier: NCT02980874
Aerpio TIME-2b – Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy
ClinicalTrials.gov Identifier: NCT03197870