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Bascom Palmer Eye Institute

Clinical Trials

Clinical trials apply the scientific method to human health. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured.

Almost 40 clinical trials, clinical outcomes, and epidemiology studies are now ongoing at Bascom Palmer Eye Institute, most are national multi-center projects. These studies are funded by the National Eye Institute (NEI), private foundations, and commercial organizations.

For additional information about Bascom Palmer’s clinical trials, please visit ClinicalTrials.gov

For additional information about clinical trials at UHealth – The University of Miami Healthcare System, click here.

Below is a list of ongoing studies at Bascom Palmer Eye Institute.

Corneal and External Diseases

Study: A Multicenter Study of the Safety and Efficacy of Bevacizumab in High-Risk Corneal Transplant Survival

Principal Investigator: Victor Perez, M.D.
Contact: Marisa Braun
954-465-2782 / mxb1423@med.miami.edu

Study: Avellino – A Multicenter, Cross-Sectional, Observational Study of the Prevalence of TGFBI Corneal Dystrophies in a North American Population Through a DNA Tested Buccal Swab.

Principal Investigator: Sonya Yoo, MD
Contact: Ailen Gutierrez
305-482-4935 / AEG155@Miami.edu
Status: Enrolling

Diabetic Retinopathy

Study: Advanced Imaging for Diabetic Retinopathy

Principal Investigator: Delia Cabrera DeBuc, Ph.D.
Contact: Sandra Pineda
305-482-5080 / spineda@med.miami.edu

Study: Intravitreous Anti-VEGF Treatment for Prevention of Vision Threatening Diabetic Retinopathy in Eyes at High Risk (Protocol W)

Principal Investigator: Justin Townsend, M.D.
Contact: Belen Rodriguez
305-326-6349 / brodrig1@med.miami.edu

Dry Eye

Study: P-321 Ophthalmic Solution

Principal Investigator: Victor Perez, M.D.
Contact: Marisa Braun
954-465-2782 / mxb1423@miami.edu
Status: Enrolling subjects with dry eye disease

Glaucoma

Study: Stop Retinal Ganglion Cell Dysfunction Study

Principal Investigator: Porciatti, Vittorio D.Sc.
Contact: Marlene Perez
305-482-4309 / marlene.perez@med.miami.edu

Study: The Efficacy and Safety of Bimatoprost SR in Patients With Open-angle Glaucoma or Ocular Hypertension

Principal Investigator: Arindel S. Maharaj, M.D., Ph.D.
Contact: Chantey Roberts
561-515-1534 / c.roberts3@med.miami.edu

Study: The AGS Second Aqueous Shunt Implant vs Transcleral Cyclophotocoagulation Treatment Study (ASSISTS)

Principal Investigator: Krishna Kishor, M.D.
Contact: Chantey Roberts
561-515-1534 / c.roberts3@med.miami.edu

LASIK

Study: An investigator-initiated trial studying the effects of pregabalin vs placebo to reduce the frequency and severity of dry eye symptoms after laser-assisted in situ keratomileusis (LASIK).

Principal Investigator: Anat Galor, MD
Contact: Ailen Gutierrez
305-482-4935 / AEG155@Miami.edu
Status: Enrolling

Leber’s Hereditary Optic Neuropathy (LHON)

Study: Safety Study of an Adeno-associated Virus Vector for Gene Therapy of LHON

Dates: 2014 -2019
Principal Investigator: John Guy, M.D.
Contact: Philip Gonzalez
305-482-4739 / jpgonzalez@med.miami.edu

Macular Degeneration

Study: A Phase III, 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

Principal Investigator: Jorge Fortun, M.D.
Contact: Lorena Larez
561-515-1523 / llarez@med.miami.edu

Study: 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

Principal Investigator: Philip Rosenfeld, M.D., Ph.D.
Contact: Maria Esquiabro
305-326-6508 / mesquiabro@med.miami.edu
Closed to Enrollment

Study: A Phase III, 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 (GX29185-Spectri)

Principal Investigator: Philip Rosenfeld, M.D., Ph.D.
Contact: Monica Arango
305-326-6351 / mrarango@med.miami.edu
Status: Closed to Enrollment

Study: A Randomized, Double-Masked, Dose-Ranging, Multicenter Study Comparing ACU-4429 with Placebo in Patients with Age-Related Macular Degeneration (AMD)

Principal Investigator: Zohar Yehoshua, M.D., MHA
Contact: Maria Esquiabro
305-326-6508 / mesquiabro@med.miami.edu
Status: Closed to Enrollment

Study: A Phase I/IIa Dose Escalation Safety Study of Subretinally Injected SAR422459, Administered to Patients with Stargardt’s Macular Degeneration

Principal Investigator: Byron Lam, M.D.
Contact: Jennifer Verriotto
305-482-5186
Status: Enrolling

Study: A Phase 2 Multicenter, Double-Masked, Randomized, Placebo- Controlled Study to Investigate the Long Term Safety, Tolerability, Pharmacokinetics and Effects of ALK-001 on the Progression of Stargardt Disease

Principal Investigator: Byron Lam, M.D.
Contact: Jennifer Verriotto
305-482-5186
Status: Enrolling

Study: 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

Principal Investigator: Jaclyn Kovach, MD
Contact: Jaclyn Kovach, MD
jkovach@med.miami.edu
Status: Enrolling

Study: Proxima – Roche A Phase II Multicenter, prospective epidemiologic study of the progression of geographic atrophy secondary to age-related macular degeneration

Principal Investigator: Jaclyn Kovach, MD
Contact: Jaclyn Kovach, MD
jkovach@med.miami.edu
Status: Enrolling

Study: (Naples) Ohr 1601 – A Phase III Study of the efficacy and safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration

Principal Investigator: Jaclyn Kovach, MD
Contact: Jaclyn Kovach, MD
jkovach@med.miami.edu
Status: Enrolling

Study: (Miami) Ohr 1601 – A Phase III Study of the efficacy and safety of Squalamine Lactate Ophthalmic Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration

Principal Investigator: Zohar Yehoshua, M.D., MHA
Contact: Ailen Gutierrez
305-482-4936/ AEG155@miami.edu

Study: Solution, 0.2% Twice Daily in Subjects with Neovascular Age-Related Macular Degeneration

Principal Investigator: Zohar Yehoshua, M.D., MHA
Contact: Ailen Gutierrez
305-482-4935 / AEG155@Miami.edu
Status: Enrolling

Study: A Randomized, Double-Masked, Placebo-Controlled, Dose-Finding, Non-Inferiority Study of X-82 plus prn ivt anti-VEGF compared to prn ivt anti-VEGF monotherapy in neovascular AMD

Principal Investigator: Philip Rosenfeld, M.D., Ph.D.
Contact: Maria Esquiabro
305-326-6508 / mesquiabro@med.miami.edu
Status: Closed to Enrollment

Study: A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients with Geographic Atrophy (GA) – POT-CP121614

Principal Investigator: Zohar Yehoshua, M.D., MHA
Contact: Ailen Gutierrez
305-482-4936 / AEG155@miami.edu
Status: Closed for Enrollment

Macular Edema

Study: Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity (Protocol V)

Principal Investigator: Justin Townsend, M.D.
Contact: Belen Rodriguez
305-326-6349 / brodrig1@med.miami.edu
Status: Closed to Enrollment

Macular Telangiectasia

Study: A Natural History Observation and Registry Study of Macular Telangiectasia Type 2

Principal Investigator: Philip Rosenfeld, M.D., Ph.D.
Contact: Cristy Lage
305-326-6117 / clage@med.miami.edu
Status: Enrolling

Study: A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel)

Principal Investigator: Philip Rosenfeld, M.D., Ph.D.
Contact: Cristy Lage
305-326-6117 / clage@med.miami.edu
Status: Closed to Enrollment

Neuro-Ophthalmology

Study: New Enrollment Post-Approval Study of the Argus II Retinal Prosthesis System

Principal Investigator: Byron Lam, M.D.
Contact: Potyra Rosa
305-482-4584

Study: Phase 2/3, Randomized, Double-Masked, Sham-Controlled Trial of QPI-1007 in Subjects With Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Principal Investigator: Byron Lam, M.D.
Contact: Potyra Rosa
prosa@med.miami.edu
Status: Enrolling

Ocular Oncology

Study: Molecular Predictive Testing in Ocular Melanoma

Principal Investigator: J. William Harbour, MD
Contact: Christina Decatur
305-326-6020
Status: Enrolling

Study: Molecular Profiling of Ocular Tumors

Principal Investigator: J. William Harbour, MD
Contact: Christina Decatur
305-326-6020
Status: Enrolling

Study: Proof of Concept Study of Vorinostat, a Histone Deacetylase Inhibitor, in Patients with Class 2 High-Risk Uveal Melanoma

Principal Investigator: Nicolas Acquavella, MD
Co-Investigator: J. William Harbour, MD
Contact: Barbara Perez
305-326-6339
Status: Enrolling

Study: Phase 1B Trial of AEB071, a PKC inhibitor, in combination with Byl719, a PI3K Inhibitor, in Patients with Metastatic Uveal Melanoma

Principal Investigator: Lynn Feun, MD
Co-Investigator: J. William Harbour, MD
Contact: Barbara Perez
305-326-6339
Status: Enrolling

Retinal Degeneration

Study: Safety and Efficacy Trial of AAV Gene Therapy in Patients With CNGB3 Achromatopsia

Principal Investigator: Byron Lam, M.D.
Contact: Potyra Rosa
prosa@med.miami.edu
Status: Enrolling

Study: Clinical Evaluation of Individuals with Achromatopsia Caused by CNGA3 Mutations natural History study

Principal Investigator: Byron Lam, M.D.
Contact: Potyra Rosa
prosa@med.miami.edu
Status: Enrolling

Strabismus and Pediatrics

Study: Pediatric Eye Disease Investigator Group

Dates: 1997-2018
Principal Investigator: Susanna Tamkins, O.D. and Craig McKeown, M.D.
Contact: Carolina Manchola-Orozco
(305) 482-4016 / cmorozco@med.miami.edu

Study: Convergence Insufficiency Treatment Trial: Attention and Reading Trial

Dates: 2014-2019
Principal Investigator: Susanna Tamkins, O.D., and Craig McKeown, M.D.
Contact: Carolina Manchola-Orozco
(305) 482-4016 / cmorozco@med.miami.edu

Uveitis

Study: Multicenter Uveitis Steroid Treatment (MUST) Follow Up Trial

Dates: 2004-2017
Principal Investigator: Janet Davis, M.D.
Contact: Carmen Huerta
(305) 326-6348 / c.huerta1@med.miami.edu

Study: A 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

Principal Investigator: Thomas Albini, M.D.
Contact: Marie Chin
305-326-6348 / mchin@med.miami.edu
Status: Enrolling

Study: Iontophoretic Delivery of Dexamethasone Phosphate

Principal Investigator: Victor Perez, M.D.
Contact: Marisa Braun
954-465-2782 / mxb1423@miami.edu
Status: Enrolling subjects with uveitis

Vitreoretinal Diseases

Study: Natural History of the Progression of Choroideremia study

Principal Investigator: Byron Lam, M.D.
Contact: Jennifer Verriotto
305-482-5186
Status: Enrolling

Study: A Prospective, Multi-center, Longitudinal, Observational Natural History Study to Evaluate Disease Progression in Subjects with Autosomal Dominant Retinitis Pigmentosa (adRP) with Misfolded Rod Opsin Mutations

Principal Investigator: Byron Lam, M.D.
Contact: Jennifer Verriotto
305-482-5186

Study: The Correlation of Paxos Checkup Mobile App To Standard In Office Visual Assessment (Clear); Macular Degeneration, Diabetic Retinopathy, Normal Eyes

Principal Investigator: Zohar Yehoshua, M.D., MHA
Contact: Monica Arango
305-326-6351 / mrarango@med.miami.edu
Status: Enrollment begins February 2017