Research

Research 2018-02-02T18:30:21+00:00

Nationally Recognized

Pacific Retina is nationally recognized and active in clinical trials for the past fifteen years. Pacific Retina’s doctors have a long history of participating in clinical trials for ground-breaking new retinal treatments. Our physicians not only participate in the nation’s largest multi-center clinical trials; our physicians have helped design new studies and innovative therapies. Ask your Pacific Retina doctor about clinical trials that are currently enrolling for conditions such as wet age-related macular degeneration, dry (atrophic) age-related macular degeneration, diabetic retinopathy and more. We are proud to have been involved in the landmark studies that brought vision saving treatments including Lucentis (ranibizumab, Genentech), Eylea (aflibercept, Regeneron), Ozurdex (dexamethasone implant, Allergan), and photodynamic therapy (visudyne, Novartis) for retinal diseases involving age related macular degeneration (wet AMD), retinal vein occlusions, and diabetic macular edema.

The physicians at Pacific Retina are dedicated to bring you the most advanced surgical and medical care available. Our research team is committed to carefully selecting well-designed, safe clinical studies that offer promising and exciting new treatments for our patients. Our clinical trials are a valuable opportunity for patients to access novel treatments for retinal diseases.

Clinical Trials

ACTIVE STUDIES

  • LADDER (Genentech)
    A 20 month, phase 2, multicenter, randomized, active treatment-controlled study of the efficacy and safety of the ranibizumab port delivery system for sustained delivery of ranibizumab in patients with subfoveal neovascular age-related macular degeneration.

COMPLETED STUDIES

  • CLEAR (DigiSight)
    A 3 month, phase 1 and 2 studies on THE CORRELATION OF PAXOS CHECKUP MOBILE APP TO STANDARD IN OFFICE VISUAL ASSESSMENT.

ACTIVE STUDIES

  • BOULEVARD (Genentech)
    A multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, parallel group, 28-week study to investigate the safety, tolerability, pharmacokinetics, and efficacy of RO6867461 administered intravitreally in patients with diabetic macular edema.
  • HULK (NCRVA and Regeneron)
    A phase I/II, 6 month, open label study of the safety and efficacy of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept for the treatment of diabetic macular edema.
  • PALADIN (Alimera)
    A 3 year, phase 4 safety study of IOP signals in patients with DME who are treated with ILUVIEN (fluocinolone acetonide intravitreal implant).

COMPLETED STUDIES

  • DEL MAR (Allegro)
    A 6 month, phase 2, multicenter, randomized, controlled, double-masked clinical trial designed to evaluate the safety and exploratory efficacy of Luminate (ALG-1001) as compared to Avastin in the treatment of diabetic macular edema.
  • ENDURANCE IIT (NCRVA & Regeneron)
    A 2 year investigator initiated study on the long-term efficacy and safety of intravitreal aflibercept (Eylea) injections for the treatment of diabetic macular edema in subjects who completed the three year VISTA-DME trial.
  • PALM (Allergan)
    A phase 2, six month study on the evaluation of Abidipar Pegol (AGN-150998) in patients with decreased vision due to diabetic macular edema.
  • PROTOCOL U (DRCR Network)
    A short-term (9 months) evaluation of combination corticosteroid (Ozurdex) + Anti-VEGF (Lucentis) Treatment for Persistent Central-Involved Diabetic Macular Edema Following Anti-VEGF Therapy.
  • RUBY (Regeneron)
    A 9 month, phase 2, randomized, double-masked study of the efficacy, safety, and tolerability of repeated doses of intravitreal REGN910-3 in patients with diabetic macular edema.
  • VISTA (Regeneron)
    A double-masked, randomized, active-controlled, phase 3 study of the efficacy and safety of intravitreal administration of VEGF Trap-Eye in patients with diabetic macular edema.

ACTIVE STUDIES

  • PANORAMA (Regeneron)
    A 2 year, Phase 3, multicenter, randomized study of the efficacy and safety of intravitreal aflibercept (Eylea) injection in patients with moderately severe to severe nonproliferative diabetic retinopathy

COMPLETED STUDIES

  • Cystoid Macular Edema after Cataract Surgery (Allergan)
    Phase 2 Study of the Dexamethasone Intravitreal Implant (Ozurdex) for combined Pseudophakic Cystoid Edema and Diabetic Macular Edema after cataract surgery.
  • DA VINCI (Regeneron)
    Phase 2 study of the safety, tolerability and biological effect of repeated aflibercept (Eylea) in diabetic macular edema.
  • DEGAS (Pfizer)
    Phase 2 study of the efficacy and safety of PF-04523655 versus laser in diabetic macular edema.
  • PACIFIC (Allegro)
    A 6 month, 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.
  • RIDE (Genentech)
    Phase 3 study of the efficacy and safety of Ranibizumab (Lucentis) in diabetic macular edema.
  • VISTA (Regeneron)
    A 3 year Phase 3 study of the efficacy, safety and tolerability of aflibercept (Eylea) in patients with diabetic macular edema.

ACTIVE STUDIES

  • BEACON (Allergan)
    A 2 year, phase 2 study on the safety and efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with geography atrophy secondary to age-related macular degeneration.
  • OMASPECT (Genentech)
    A multicenter, open-label extension study to evaluate the long-term safety and tolerability of lampalizumab in patients with geographic atrophy secondary to age-related macular degeneration who have completed a roche-sponsored study.
  • SPECTRI (Genentech)
    A 2 year, phase 3, multicenter, randomized, double-masked, sham-controlled study to assess the efficacy and safety of Lampalizumab administered intravitreally to patients with Geographic Atrophy secondary to Age-Related Macular Degeneration.
  • TARGETing GA (Santen Inc.)
    Non-interventional, cross-sectional study of Alu RNA measurement and complement factor genotyping of single nucleotide polymorphisms in the complement pathway in patients with geographic atrophy associated with dry age-related macular degeneration.

COMPLETED STUDIES

  • ICON (Pfizer)
    A 1 year Phase 2 study examining a monoclonal antibody to decrease the amount of drusen in the eyes seen in people with Dry AMD with an intravenous infusion.
  • PREVENT IIT (NCRVA & Genentech)
    A 2 year investigator initiated study on prophylactic Ranibizumab for exudative age-related macular degeneration (AMD) in vulnerable eyes with Non exudative AMD Trial.
  • SEATTLE (Acucela)
    A 2 year Phase 2/3 study which aims to reduce the rate of Dry AMD progression with the use of an pill.

ACTIVE STUDIES

  • CLKA651X2104 (Novartis)
    A phase 1, 3 month, randomized, single-masked, sham-control, single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics activity of intravitreal LKA651 in patients with macular edema from diabetic macular edema, neovascular age-related macular degeneration, or retina vein occlusions.

ACTIVE STUDIES

  • SAPPHIRE (Clearside Biomedical)
    A phase 3, 12 month, 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.
  • SCORE2 Long Term Follow-Up Phase (NEI)
    A multicenter, non-interventional extension study to understand the long-term efficacy and safety of anti-VEGF treatments on SCORE2 participants who completed the 12 month parent study.

COMPLETED STUDIES

  • BRAVO (Genentech)
    Phase 3 study of the efficacy and safety of ranibizumab (Lucentis) compared to sham injection in Branch Retinal Vein Occlusions.
  • COPERNICUS (Regeneron)
    Phase 3 study of the safety, tolerability and biological effect of aflibercept (Eylea) for Central Retinal Vein Occlusions.
  • CRUISE (Genentech)
    Phase 3 study of the efficacy and safety of ranibizumab (Lucentis) compared to sham injection in Central Retinal Vein Occlusions.
  • GENEVA (Allergan)
    Phase 3 study of the efficacy of the Dexamethasone Intravitreal Implant (Ozurdex) in Retinal Vein Occlusions.
  • ICON (ICON Biosciences)
    Phase 1 open label dose escalation study of the safety and tolerability of a sustained release Intravitreal Liquid Drug Delivery using Triamcinolone Acetonide.
  • NEWTON (NCRVA and Regeneron)
    A 1 year Prospective study of Aflibercept (Eylea) for previously treated Macular Edema associated with Central Retinal Vein Occlusion.
  • SCORE2 (NEI)
    A 1 year study of comparative treatment between bevacizumab (Avastin) and aflibercept (Eylea) for Retinal Vein Occlusion.
  • SHORE (Genentech)
    Phase 4 study evaluating different dosing regimens of ranibizumab (Lucentis).
  • VIBRANT (Regeneron)
    A 1 year, Phase 3 study of the efficacy, safety and tolerability of aflibercept (Eylea) compared to Laser for the treatment of Branch Retinal Vein Occlusion.

ACTIVE STUDIES

  • AZALEA (Clearside Biomedical)
    A phase 3, open-label safety study of suprachoroidal triamcinolone acetonide injectable suspension in patients with non-infectious uveitis.
  • MAGNOLIA (Clearside Biomedical)
    A multicenter, non-interventional extension study of the safety and efficacy of CLS-TA for the treatment of macular edema associated with non-infectious uveitis.
  • PEACHTREE (Clearside Biomedical)
    A 6 month, phase 3, randomized, masked, controlled clinical trial to study the safety and efficacy and safety of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the treatment of subjects with Macular Edema associated with Non-Infectious Uveitis.

COMPLETED STUDIES

  • DOGWOOD (Clearside)
    A phase 2, 6 month, randomized, masked, multicenter study to assess the safety and efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the treatment of subjects with macular edema following uveitis.
  • LX211-11 (LUX BIOSCIENCE)
    Phase 3 study of the efficacy and safety of voclosporin for non-infectious uveitis.
  • SAKURA (SANTEN)
    A 2 year Phase 3 active treatment controlled study assessing the efficacy and safety of Sirolimus for the treatment of non-infectious uveitis.
  • TAHOE (NCRVA and Allergan)
    A 6 month Prospective study of the Dexamethasone Intravitreal Implant (Ozurdex) for Uveitic Macular Edema.
  • VITRASERT
    The use of a sustained-release ganciclovir implant to treat Cytomegalovirus Retinitis.

COMPLETED STUDIES

  • RELEASE
    Expansile Gas (SF6) for Symptomatic Vitreomacular Adhesion.

ACTIVE STUDIES

  • CEDAR (Allergan)
    A 2 year, phase 3 study on the safety and efficacy of Abicipar Pegol (AGN-150998) in patients with neovascular age-related macular degeneration.
  • HAWK (Alcon)
    A phase 3, two-year, randomized, double-masked, multicenter, three-arm study comparing the efficacy and safety of RTH258 versus aflibercept in subjects with neovascular age-related macular degeneration.
  • LADDER (Genentech)
    A 20 month, phase 2, multicenter, randomized, active treatment-controlled study of the efficacy and safety of the ranibizumab port delivery system for sustained delivery of ranibizumab in patients with subfoveal neovascular age-related macular degeneration.
  • ONYX (Regeneron)
    A 9 month, 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.
  • SF0166-C-002(SciFluor Life Sciences)
    A Phase I/II,2 month, 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.

COMPLETED STUDIES

  • ANCHOR (Genentech)
    Phase 3 double masked active treatment of the efficacy and safety of ranibizumab (Lucentis) compared to Visudyne for the treatment of Wet AMD.
  • CABERNET (Neovista)
    Phase 3 study for the use of radiation with the Epi-Rad 90 system to treat Wet AMD.
  • CAPELLA (Regeneron)
    A 1 year, phase2, double-masked, randomized, controlled, multiple-dose, regimen-ranging study of the efficacy and safety of intravitreal REGN2176-3 in patients with neovascular age-related macular degeneration.
  • ECLIPSE (Ophthotech)
    A 2 year Phase 3 study to determine the safety and efficacy of E10030 (Fovista) in combination with ranibizumab (Lucentis) compared to ranibizumab (Lucentis) monotherapy in Wet AMD.
  • EMERGE (Iconic Therapeutics)
    A 6 month, phase 2, randomized, double-masked, multicenter, active-controlled study evaluating administration of repeated intravitreal doses of hI-con1 in patients with choroidal neovascularization secondary to age-related macular degeneration.
  • HARBOR (Genentech)
    Phase 3 randomized treatment study of the efficacy and safety of different doses of ranibizumab (Lucentis) administered monthly or as needed.
  • HORIZON (Genentech)
    Follow up study to evaluate the safety and tolerability of ranibizumab (Lucentis).
  • MARINA (Genentech)
    Phase 3 double masked active treatment controlled study of the efficacy and safety of ranibizumab (Lucentis).
  • NEXUS (Lpath)
    A 9 month Phase 2A study that is evaluating ISONEP as either monotherapy or adjunctive therapy to ranibizumab (Lucentis), bevacizumab (Avastin) or aflibercept (Eylea).
  • OPH1004 (Ophthotech)
    A 2 year, phase2, 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 Avastion or Eylea monotherapy in subjects with subfoveal neovascular age-related macular degeneration.
  • OSPREY (Alcon)
    A 1 year Phase 2 study that will determine the safety, tolerability and efficacy of ESBA 1008 vs aflibercept (Eylea) in Wet AMD.
  • OWL (Alcon)
    A 2 month Phase 2 study to evaluate the effect of ESBA 1008 applied by Microvolume Injection or Infusion in Wet AMD.
  • PAVE (Santen)
    A 3 month, phase 1, open-label, dose-escalating, sequential-cohort study assessing the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal injection of DE-122 injectable solution for the treatment of refractory exudative age-related macular degeneration.
  • REACH Stage 2 (Allergan)
    Phase 2 study of the safety and efficacy of AGN-150998 versus ranibizumab (Lucentis) in treatment-naive patients with advanced AMD.
  • REACH Stage 3 (Allergan)
    A 6 month Phase 2 study of the safety and efficacy of AGN-150998 vs ranibizumab (Lucentis) in treatment-naive patients with Wet AMD.
  • RESCUE (NCRVA & Genentech)
    A 1 year Study evaluating ranibizumab (Lucentis) in Wet AMD patients previously treated with bevacizumab (Avastin) AND aflibercept (Eylea).
  • SAILOR (Genentech)
    A comparative study evaluating the different doses of ranibizumab (Lucentis).
  • SEE (Alcon)
    Phase 2 study of the safety, tolerability and efficacy of ESBA 1008 versus ranibizumab (Lucentis) in advanced AMD.
  • TAP (Novartis)
    Phase 3 study of the efficacy and safety of Verteporfin with Photodynamic Therapy for the treatment of Wet AMD.
  • VIEW (Regeneron)
    Phase 3 Study of the efficacy, tolerability and safety of repeated doses of aflibercept (Eylea).
  • VIEW EXTENSION (Regeneron)
    Follow Up study for the patients treated with aflibercept (Eylea) for Wet AMD in the VIEW study.

FAQs

WHAT ARE CLINICAL TRIALS?

Clinical trials are voluntary research studies of human beings that are designed to answer specific health questions and necessary for the approval of new treatments.

Individuals volunteer to participate in clinical trials for a variety of reasons. Participation allows access to new treatments that are not available to the general public. Clinical trials are monitored very carefully, with additional testing with no additional cost. Finally, some volunteers take pleasure in helping others by contributing to medical research and potentially benefiting many patients with similar conditions in the future.

WHAT IS A RESEARCH COORDINATOR?

NCRVA Research Clinical Coordinators have extensive experience in coordinating clinical studies and would be the patient’s point of contact once your physician has established you as a potential subject. They help answer questions regarding the logistics of the study and coordinate your care. They are well versed with each study protocol to advocate for the safety and well-being of each participant.

WHAT ARE THE PHASES IN A CLINICAL TRIAL?

Phase 1 Trials: A small number of participants are used to test an investigational drug or treatment. The main focus is to determine the safety of the drug in humans. They evaluate the safe dose range and identify possible side effects from the drug/treatment.

Phase 2 Trials: After completing the Phase I trials, the information is used to treat a slightly larger limited number of participants. Phase II uses the information gathered from Phase I to further evaluate the safety and effectiveness of the drug/treatment.

Phase 3 Trials: The experimental treatment is given to a large group of participants in a variety of clinical settings to evaluate its safety, effectiveness and to monitor the side effects.

Phase 4 Trials: Once the drug has been approved by the FDA, this is when post marketing studies are conducted to continue to gain more information about the benefits and safety of the drug.