Vision Research & Clinical Trials Havener Eye Institute Jenna Rajczyk Demarcus Williams 13 April 2018

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Rosanna Haynes
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1 Vision Research & Clinical Trials Havener Eye Institute Jenna Rajczyk Demarcus Williams 13 April 2018

2 Our Journey to Clinical Research

3 Types of Research Animal Behavioral Basic/Fundamental Translational Clinical (Human Subjects)

4 4 What is Human Subjects Research?

5 What is Human Subjects Research? Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Human subject: a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information. 5

6 Human Subjects Research at Havener Eye Institute Interventional (clinical trials) Observational (clinical studies) Translational Longitudinal 6

7 Clinical Trial vs Clinical Study? Clinical Research Design No Intervention Intervention Observational Experimental Comparison Group Random Allocation Yes No Yes No Analytical study (case control, cohort) Descriptive Study Randomized Controlled Trial Non-Randomized

8 OPTHEA Clinical Trial Primary Objective To determine the efficacy of two different doses of intravitreal OPT-302 when administered in combination with Lucentis in patients with wet AMD Primary Endpoint The primary endpoint is mean change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) letters.

9 Ophthalmology Clinical Trial & Public Health Implications An example: Early Treatment Diabetic Retinopathy Study (EDTRS) Primary Question: When in the course of diabetic retinopathy is it most effective to initiate treatment, specifically photocoagulation?

10 Corneal Biomechanics in Ocular Disease Study Uses various devices to define the relationship between intraocular pressure (IOP) and corneal stiffness under an applied air pulse Recruitment cohorts Healthy eye volunteers Diabetic Primary Open Angle Glaucoma Ocular Hypertension Keratoconus Age-Matched Recruitment

11 Translational Research Applies discoveries generated in the lab or preclinical studies to the development in trials and studies in humans Basic Research Clinical Research Improved Health

12 Measurements of Corneoscleral Biomechanics Using Ultrasound Developed high-frequency ultrasound imaging device Will aid in detecting and diagnosing various corneal pathology and glaucoma

13 Ocular Hypertension Treatment Study Stage 1 (1994): Determine the safety & efficacy of topical ocular hypotension medication Stage 2 (2002): Compare safety & efficacy of earlier vs later treatment in preventing Primary Open-Angle Glaucoma (POAG) Stage 3 (2015): Determine the 20-year incidence of POAG & develop a 20-year glaucoma prediction model

14 Closing Remarks

15 References Glaucoma Projected to Increase Significantly Due To Aging U.S. Population. (n.d.). Retrieved April 10, 2018, from http://www.preventblindness.

Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, et al. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010;128(3):276-87.

15 15 References Glaucoma Projected to Increase Significantly Due To Aging U.S. Population. (n.d.). Retrieved April 10, 2018, from Kass MA. The ocular hypertension treatment study. J Glaucoma. 1994;3(2): Kass MA, Gordon MO, Gao F, Heuer DK, Higginbotham EJ, Johnson CA, et al. Delaying treatment of ocular hypertension: the ocular hypertension treatment study. Arch Ophthalmol. 2010;128(3): Protecting Human Subjects. Protecting Human Subjects UCSF Institutional Review Board, 1 Jan. 1970, irb.ucsf.edu/. Royle P, Mistry H, Auguste P, et al. Pan-retinal photocoagulation and other forms of laser treatment and drug therapies for non-proliferative diabetic retinopathy: systematic review and economic evaluation. Southampton (UK): NIHR Journals Library; 2015 Jul. (Health Technology Assessment, No ) Chapter 2, The landmark trials: Diabetic Retinopathy Study and Early Treatment Diabetic Retinopathy Study.Available from: Rubio, D. M., Schoenbaum, E. E., Lee, L. S., Schteingart, D. E., Marantz, P. R., Anderson, K. E., Esposito, K. (2010). Defining Translational Research: Implications for Training. Academic Medicine : Journal of the Association of American Medical Colleges, 85(3),

MEASURING THE SIZE OF A TREATMENT EFFECT: RELATIVE RISK REDUCTION, ABSOLUTE RISK REDUCTION, AND NUMBER NEEDED TO TREAT

MEASURING THE SIZE OF A TREATMENT EFFECT: RELATIVE RISK REDUCTION, ABSOLUTE RISK REDUCTION, AND NUMBER NEEDED TO TREAT Hussein Hollands, MD, MS (epid) Peter J. Kertes, MD, CM, FRCS(C) 72 The purpose of