Research & Trials

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.

CURRENTLY ENROLLING

Wet Age-Related Macular Degeneration

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

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

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

Diabetic Macular Edema

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

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

Retinal Vein Occlusion

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

Diabetic Retinopathy

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

Uveitis

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

CLOSED TO ENROLLMENT

XOMA 131 – A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Subjects With Non-infectious Intermediate, Posterior, or Pan-uveitis Currently Controlled With Systemic Treatment.
ClinicalTrials.gov identifier: NCT01747538

Allegro DME 202-B – A Phase 2 randomized, controlled, double-masked, multicenter clinical trial designed to evaluate the safety and exploratory efficacy of Luminate (ALG-1001) as compared to Avastin and Focal Laser Photocoagulation in the Treatment of Diabetic Macular Edema.
ClinicalTrials.gov Identifier: NCT02348918

Alcon RTH258-E003 (PK Study) – The purpose of this study is to assess the systemic pharmacokinetics (PK) of RTH258 in subjects (Japanese and non-Japanese ethnicity) with neovascular Age-Related Macular Degeneration (AMD).
ClinicalTrials.gov Identifier:NCT02507388

Score 2 – Study of Comparative Treatments for Retinal Vein Occlusion 2 [SCORE2] – a Multicenter, Prospective, Randomized Non-inferiority Trial of Eyes With Macular Edema Secondary to Central Retinal Vein Occlusion, Comparing Intravitreal Bevacizumab Every 4 Weeks With Intravitreal Aflibercept Every 4 Weeks.
ClinicalTrials.gov identifier: NCT01969708

Ophthotech 1002 – 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 Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
ClinicalTrials.gov identifier: NCT01944839

PanOptica– A Phase I Open-Label, Multi-Center Trial With Randomization to Dose to Evaluate the Safety and Tolerability of Topical Ocular PAN-90806 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
ClinicalTrials.gov identifier: NCT02022540

Pfizer B1261009 – A Phase 2, Randomized, Double-Masked, Placebo-Controlled, Parallel Group, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist (PF-04634817) With That Of Ranibizumab In Adult Subjects With Diabetic Macular Edema.
ClinicalTrials.gov identifier: NCT01994291

Regeneron REGN910 – This is a double-masked, randomized, multi-center clinical study designed to evaluate the safety and anatomic effects of REGN910 alone and in conjunction with intravitreal (IVT) aflibercept injection in patients with DME.
ClinicalTrials.gov identifier: NCT01997164

Xcovery Vision– 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

XOMA 130 – A Randomized, Double-masked, Placebo-controlled Study of the Safety and Efficacy of Gevokizumab in the Treatment of Active Non-infectious Intermediate, Posterior, or Pan- Uveitis.
ClinicalTrials.gov identifier: NCT01684345

Re-View – An Open-Label Study of the Efficacy, Safety and Tolerability of Intravitreal Administration of VEGF Trap-Eye (Intravitreal Afibercept Injection) in patients with Neovascular Age-Related Macular Degeneration (Wet) With emphasis on Endothelial Cell Counts using a specular microscope.
ClinicalTrials.gov identifier NCT01722045

LFG316A2203 – A Multicenter, Randomized, Sham-control, Proof-of-concept Study of Intravitreal LFG316 in Patients With Geographic Atrophy Associated With Age-Related Macular Degeneration.
ClinicalTrials.gov identifier NCT01527500

Aerpio – A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema.
ClinicalTrials.gov identifier: NCT02050828

Allergan Cypress – This is a phase 2 safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration.
ClinicalTrials.gov identifier: NCT02181517

Allergan Palm– This is a phase 2 safety and efficacy study of abicipar pegol in patients with diabetic macular edema.
ClinicalTrials.gov identifier: NCT02186119

Genentech GX01456 – A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of FCFD4514S in Patients with Geographic Atrophy.
ClinicalTrials.gov identifier: NCT01602120

Lpath-003/Nexus Study – A Phase2a, Multi-center, Masked, Randomized, Comparator Controlled Study Evaluating iSONEP as Monotherapy or Adjunctive Therapy to Lucentis/Avastin versus Lucentis /Avastin Alone for the treatment of Subjects with Choroidal Neovascularization Secondary to Age related Macular Degeneration.
ClinicalTrials.gov identifier NCT01414153

Opthea – A Phase 1 Dose Escalation Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 in Combination With Ranibizumab in Subjects With Wet AMD
ClinicalTrials.gov identifier: NCT02543229

Ophthotech 1004 – 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.
ClinicalTrials.gov identifier: NCT01940887

Iconic Theraputics EMERGE– The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
ClinicalTrials.gov Identifier: NCT02358889

Neurotech NT-503-3 ECT – A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology Compared With Eylea for the Treatment of Recurrent CNV Secondary to AMD
ClinicalTrials.gov Identifier: NCT02228304

Regeneron 1417 – The primary objective of the study is to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.
ClinicalTrials.gov Identifier: NCT02418754

Alcon Hawk- RTH258-C001 – The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT) injection at two dosage levels to aflibercept solution for IVT injection (2 mg) in subjects with untreated active choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye.
ClinicalTrials.gov Identifier: NCT02307682

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

Allergan Beacon – This study will assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration.
ClinicalTrials.gov Identifier:NCT02087085

Astellas-VIDI – A Phase 2, Double-Masked, Randomized, Active Controlled Study to Evaluate the Efficacy and Safety of ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema.
ClinicalTrials.gov identifier: NCT02302079

ORION
– CRVO occurs when the vessels in the back of the eye become blocked. This creates a dangerous condition because the vessels are weak and prone to leakage. This results in the development of macular edema.Previous studies have shown that inflammatory mediators and growth factors, such as vascular endothelial growth factor (VEGF), are elevated in patients with macular edema associated with CRVO.

Ozurdex® is approved by the Food and Drug Administration (FDA) and is available by prescription for macular edema following CRVO and branch retinal vein occlusion (BRVO). It is also indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. The approved dosage is 0.7 mg.

Ranibizumab (Lucentis®) is approved by the Food and Drug Administration (FDA) and is available by prescription for other eye disorders, such as wet age-related macular degeneration (AMD), macular edema following CRVO or BRVO, and diabetic macular edema (DME). The approved dosage for wet AMD and macular edema following CRVO/BROV is 0.5 mg given monthly. The approved dosage for DME is 0.3 mg given monthly.

Dr. Gonzalez is conducting an investigational study on the safety and effectiveness of treating CRVO-associated Macular Edema with a combination of 0.7 mg of Ozurdex® and 0.5 mg Lucentis®, given as separate injections into the eye.

ClinicalTrials.gov identifier: NCT01827722

Allegro PVD 202 – A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.
ClinicalTrials.gov Identifier: NCT02435862

Santen-Sukura – A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study for the Treatment of Active, Non-Infectious Uveitis.
ClinicalTrials.gov identifier: NCT01358266

Research & Trials