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Pilot Phase I/II Study of the Evaluation of Interferon Gamma-1B

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Pilot Phase I/II Study of the Evaluation of Interferon Gamma-1B RCD ESCS May 27, 2016 Protocol Title: Pilot Phase I/II Study of the Evaluation of Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS) Protocol Number: 15-EI-0052 Date of This Submission/Version: May 27, 2016/ v5.0 Principal Investigator (PI) Bldg. 10, Wadih Zein, MD NEI/NIH 301-496-8118 [email protected] Rm. 10D45 Accountable Investigator Bldg. 10, Wadih Zein, MD NEI/NIH 301-496-8118 [email protected] Rm. 10D45 Associate Investigators (AI) Bldg. 10, Catherine Cukras, MD, PhD NEI/NIH 301-435-5061 [email protected] Rm. 10C438 Bldg. 10, Brett Jeffrey, PhD NEI/NIH 301-402-2391 [email protected] Rm. 10C442 Bldg. 10, Emily Chew, MD NEI/NIH 301-496-6583 [email protected] Rm. 3-2531 Bldg. 10, Amy Turriff, ScM NEI/NIH 301-402-4175 [email protected] Rm. 11C432B Bldg. 10, Henry Wiley, MD NEI/NIH 301-451-4260 [email protected] Rm. 10D45 Bldg. 6, Wai T. Wong, MD, PhD NEINIH 301-496-7566 [email protected] Rm. 217 Bldg. 10, Brian Brooks, MD, PhD NEI/NIH 301-451-2238 [email protected] Room 10B16 Bldg. 35, Kapil Bharti, PhD NEI/NIH 301-496-9661 [email protected] Rm. 2A-102 Bldg. 6, Anand Swaroop, PhD NEI/NIH 301-435-5754 [email protected] Rm. 338 Bldg. 10, Arvydas Maminishkis, PhD NEI/NIH 301-435-4902 [email protected] Rm. 10B04 Bldg. 31, Sheldon Miller, PhD NEI/NIH 301-496-3180 [email protected] Rm. 6A22 Bldg. 10, H. Nida Sen, MD, MHSc NEI/NIH 301-402-3254 [email protected] Rm. 10N112 Bldg. 10, Laryssa Huryn, MD NEI/NIH 301-443-8556 [email protected] Rm. 10D45 Bldg. 10, Robert Hufnagel, MD, PhD NEI/NIH 301-496-3577 [email protected] Rm, 10D45 Bldg. 10 Allison Bamji, RN NEI/NIH 301-451-3437 [email protected] Rm. 10D45 Bldg. 10 Angel Garced, BSN, MPH NEI/NIH 301-594-3141 [email protected] Rm. 10C408 Version 5.0 CONFIDENTIAL Page i RCD ESCS May 27, 2016 Referral Contact Bldg. 10 Angel Garced, BSN, MPH NEI/NIH 301-594-3141 [email protected] Rm. 10C408 Human Research Protections Program Investigator and Staff Training: For this protocol, the following “Just in time” human subjects protection training courses are required for investigators and staff: Biomedical-Vulnerable Subjects-Research with Children Coordinating Center : The Emmes Corporation (Emmes) 401 North Washington St. Suite 700 Rockville, MD 20850 USA Phone: (301) 251-1161 Facsimile: (202) 478-0243 Total Requested Accrual: 12 Participants: • Up to 5 Participants with Rod-cone dystrophy and macular edema • Up to 5 Participants with Enhanced S-cone syndrome and macular edema • Up to an additional two participants may be enrolled to account for participants who withdraw from the study prior to receiving five days of treatment 0 Healthy Volunteers Project Uses Ionizing Radiation: No Yes IND/IDE: No Yes Drug #: 105,631 Sponsor: Wadih Zein, MD, National Eye Institute Durable Power of Attorney: No Yes Multi-institutional Project: No Yes Data and Safety Monitoring Board: No Yes Version 5.0 CONFIDENTIAL Page ii RCD ESCS May 27, 2016 Technology Transfer Agreement: No Yes Agreement type and number: CTA 00935-13 with Horizon Pharma [Vidara Therapeutics Research Limited (Vidara)] Expiration Date: September 30, 2016 Samples Being Stored for Future Research: No Yes Flesch-Kincaid Reading Level of Consent Form: 8.6 Flesch-Kincaid Reading Level of Assent Form: 5.7 Version 5.0 CONFIDENTIAL Page iii RCD ESCS May 27, 2016 TABLE OF CONTENTS PROTOCOL ABBREVIATION LIST .................................................................................................. VI PRÉCIS ............................................................................................................................................ 1 1.0 INTRODUCTION/SCIENTIFIC RATIONALE ........................................................................... 3 2.0 STUDY OBJECTIVES ............................................................................................................. 5 3.0 PARTICIPANTS ..................................................................................................................... 5 3.1 Participant Eligibility Criteria .......................................................................................... 6 3.1.1 Inclusion Criteria ...................................................................................................... 6 3.1.2 Exclusion Criteria ..................................................................................................... 6 3.2 Study Eye Eligibility Criteria ........................................................................................... 7 3.2.1 Study Eye Inclusion Criteria ..................................................................................... 7 3.2.2 Study Eye Exclusion Criteria .................................................................................... 7 3.2.3 Study Eye Selection Criteria in Cases of Bilateral Disease ...................................... 7 4.0 STUDY DESIGN AND METHODS ........................................................................................... 8 4.1 Study Overview ................................................................................................................ 8 4.2 Recruitment ...................................................................................................................... 8 4.3 Screening .......................................................................................................................... 9 4.4 Study Visits ...................................................................................................................... 9 4.4.1 Study Evaluations ................................................................................................... 11 4.5 Study and Concomitant Therapies ................................................................................. 12 4.5.1 Product Overview ................................................................................................... 12 4.5.2 Investigational New Drug (IND) Requirement....................................................... 12 4.5.3 Preparation and Administration .............................................................................. 12 4.5.4 Drug Accountability................................................................................................ 13 4.5.5 Concomitant Medications and Treatments ............................................................. 13 4.6 Follow-up/Termination Procedures................................................................................ 14 4.7 Storage of Samples and Data ......................................................................................... 14 5.0 RISKS AND DISCOMFORTS ................................................................................................. 15 5.1 Risks and Discomforts Associated with the Clinical Assessments ................................ 15 5.2 Risks and Discomforts Associated with the Investigational Product ............................. 16 6.0 PARTICIPANT MONITORING .............................................................................................. 17 6.1 Participant Withdrawal Criteria ..................................................................................... 17 6.2 Reporting of Pregnancy .................................................................................................. 18 7.0 OUTCOME MEASURES ....................................................................................................... 18 7.1 Primary Outcome Measures ........................................................................................... 18 7.2 Secondary Outcome Measures ....................................................................................... 18 8.0 STATISTICAL ANALYSIS .................................................................................................... 19 8.1 Analysis .......................................................................................................................... 19 Version 5.0 CONFIDENTIAL Page iv RCD ESCS May 27, 2016 8.2 Sample Size .................................................................................................................... 19 9.0 HUMAN SUBJECTS PROTECTION ....................................................................................... 19 9.1 Equitability ..................................................................................................................... 19 9.1.1 Justification for Exclusion of Children Below 12 Years of Age ............................ 20 9.1.2 Justification for Inclusion of Children Ages 12 and Above ................................... 20 9.1.3 Safeguards for Vulnerable Populations .................................................................. 20 9.1.4 Consideration of Persons Who Cannot Consent ..................................................... 20 9.1.5 Justification for Exclusion of Pregnant or Lactating Women ................................. 21 9.2 Qualifications of Investigators ....................................................................................... 21 10.0 ANTICIPATED BENEFIT...................................................................................................... 23 11.0 CLASSIFICATION OF RISK ................................................................................................. 23 12.0 CONSENT DOCUMENTS AND PROCESS .............................................................................. 24
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