UNM Department of Surgery

Department of Surgery
Ophthalmology Division

UNM School of Medicine
MSC 10 5610
1 University of New Mexico
Albuquerque, New Mexico 87131
> Phone: (505) 272-6120

Ophthalmology

Clinical Research

Current Studies

All studies have been approved by the Institutional Review Board.

Studies

DRCR Protocol T
A Comparative effectiveness study of intravitreal aflibercept, bevacizumab and ranibizumab for diabetic macular edema
Objective: This multi-site study compares the effectiveness of three drugs commonly used to treat the edema of the macula in the eyes of diabetic patients.
Sponsor: National Institute of Health (NIH) funding to the DRCR network, collaborative network dedicated to facilitating multicenter clinical research of diabetic retinopathy, diabetic macular edema and associated conditions.
Primary Investigator: Arup Das, MD, PhD
Coordinator: Linda Friesen

ATS18 - Amblyopia Treatment Study NCT02200211
Study of Binocular Computer Activities for Treatment of Amblyopia
Objective: To compare the effectiveness of 1 hour/day of binocular game play 7 days per week (minimum of 4 days per week) with 2 hours/day of patching 7 days per week, in children 13 to 17 years of age (older cohort), as a superiority study.
Sponsor: National Institute of Health (NIH) funding to the Pediatric Eye Disease Investigator Group (PEDIG), collaborative network dedicated to facilitating multicenter clinical research
Primary Investigator: Timothy W. Winter
Coordinator: Linda Friesen

DPPOS Study
Diabetes Prevention Program Outcomes Study
Objective: A multi-center clinical trial that examines the efficacy of an intensive lifestyle intervention or metformin to prevent or delay the development of Type 2 diabetes in a population selected to be high-risk due to the presence of impaired glucose tolerance.
Sponsor: National Institutes of Health (NIH)
Investigator: Arup Das, MD, PhD; Primary Investigator: David Schade, MD
Clinical Coordinator: Penny Hyde, RN

EDIC Study
Epidemiology of Diabetes Interventions and Complications
Objective: This is the national long-term follow-up study of the same group studied in the Diabetes Control and Complications Trial (DCCT). The volunteers in this study have type1 diabetes. EDIC follows these participants to find out if intensive therapy provides risk reduction for retinopathy, nephropathy and neuropathy.
Sponsor: National Institutes of Health (NIH); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator : David Schade, MD
Investigator: Arup Das, MD, PhD
Clinical Coordinator: Janene Canady, RN

Completed Studies

Use of Ranibizumab to Control Pterygium
The use of Ranibizumab to control pterygium growth in recurrences and in non-surgical primary lesions
Objective: The primary objective in this open label Phase I study is to evaluate the safety and efficacy of Ranibizumab given via a subtenon injection for the treatment of pterygium lesions. All study visits have been completed and data is being analyzed.
Sponsor: Genentech
Principal Investigator: Linda Rose, MD, PhD

RIDE Study
A Phase III, Double-Masked, Multicenter, Randomized, Sham-Injection Controlled Study of the Efficacy and Safety of Ranibizumab (Lucentis) Injection in Subjects with Clinically Significant Macular Edema with Center involvement Secondary to Diabetes Mellitus
Objective: This clinical trial evaluated the safety and effectiveness of ranibizumab for diabetic macular edema, the major cause of significant visual loss in diabetics. Data from this and other studies was used to gain FDA approval for the use of ranibizumab in the treatment of diabetic macular edema.
Sponsor: Genentech, Inc.
Principal Investigators: Arup Das, MD, PhD; Bob Avery, MD, PhD
Clinical Coordinator: Sheila Nemeth, COMT; Linda Friesen

READ-2 Study
Ranibizumab (Lucentis) for Edema of the Macula in Diabetes: a Phase II Study
Objective: This is a multi-center clinical trial examined the effectiveness and safety of ranibizumab, with or without laser treatment, compared to laser-only treatment for diabetic macular edema.
Sponsor: Sponsor: Juvenile Diabetes Research Foundation and Genentech, Inc.
Primary Investigator: Arup Das, MD, PhD
Clinical Coordinator: Sheila Nemeth, COMT

Lupus Study
Libman-Sacks Endocarditis as a Cause of Neuropsychiatric Systemic Lupus Erythematosus
Objective: A four-year study examined whether microthrombi in patients with valvular heart diseases cause the cerebral lesions in neuropsychiatric systemic lupus erythematosus. The study included examination of retinas of these patients for retinal microemboli and retinal atherosclerosis lesions.
Sponsor: National Heart, Lung and Blood Institute (NIH)
Primary Investigator: Carlos Roldan, MD
Investigator: Arlene Bagga, MD
Clinical Coordinator: Janeen Sharrar, R.N.

Novartis FTY720 Study
A 24-month double-blind, randomized, multicenter, placebo-controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus placebo in patients with relapsing-remitting multiple sclerosis (MS)
Objective: A two year study will provide efficacy, safety and tolerability data of fingolimod (FTY720-oral drug) compared with placebo in patients with relapsing remitting multiple sclerosis.) Fingolimod has been previously associated with a two-fold increase in the risk of macular edema in renal transplant patients. Although there have been no confirmed cases of macular edema in MS, careful ophthalmic monitoring is being implemented in this study for early detection of this event.
Sponsor: Novartis
Primary Investigator: Corey Ford, MD
Investigator: Thomas Carlow, MD
Clinical Coordinator: Lori Bachert