Raoul P Scholtz, MB CHB, DCH, FCS, Ophthalmology
Consultant to Groote Schuur Hospital, Cape Town, eye cancer service.
MCC Format for Investigator
Title of Trial: A Multi-Center, Two-Stage, Open-Label Phase I and Randomized, Active Controlled, Masked Phase II Study to Evaluate the Safety and Efficacy of Intravitreal Implantation of NT-503-3 Encapsulated Cell Technology for the Treatment of Recurrent Subfoveal Choroidal Neovascularization (CNV) secondary to Age Related Macular Degeneration (AMD)
Protocol Number: NT-503-3- AMD-003
Title: Dr Initials: R.P.
Full First Names: Raoul Pierre
Surname / Organization: SCHOLTZ
HPCSA No: MP 0249335
Current personal medical malpractice insurance details [medical and dental practitioners]:
Medical Protection Society Member no: 08/9466
SITE / INSTITUTION DETAILS
Site / Institution Name: Dr J Acton – Principal Investigator
(Dr R Scholtz – Sub-Investigator)
Postal Address: P.O Box 19076
Postal Code: 7505
Physical Address: Dr J Acton Dr R Scholtz
7A Oosterzee Street Melrose House
Bellville 7530 14 Palmyra Road
Cape Town Claremont
South Africa Cape Town
Telephone No: +27 21 671 5154 Fax No: +27 21 683 1124
Cellphone No: +27 83 381 4542 E-Mail: email@example.com
Academic Qualifications: (including year and institution)
Date Qualification Institution
1976 - 1981 MBChB (UCT) University of Cape Town, Cape Town, South Africa
1986 DCH (SA) College of Medicine of South Africa.
1992 FCS (SA) Ophthalmology College of Medicine of South Africa.
1992-1995 In-house Retina Training Dept of Ophthalmology, University of Cape Town, South Africa
Date of Last GCP Course: 06 Feb 2013
GCP Course Provider: Wits Health Consortium
National Principal Investigator
Contract Research Affiliate
Relevant related work experience (brief) and current position:
1982 - 1983
Internship - Edendale Hospital, Pietermaritzburg, South Africa
Medical Officer (M.O.)- Anaesthetics , Edendale, South Africa
1986 Medical Officer, Anaesthetics, Tygerberg Hospital. South Africa
Senior House Officer (S.H.O.) - Paediatrics, Red Cross War Memorial Children's Hospital, South Africa
Diploma in Child Health (D.C.H.), South Africa
1987 - 1988 Senior House Officer - Obstetrics and Gynaecology, Tygerberg Hospital, South Africa
Medical Officer, Casualty and Department of Surgery, Victoria Hospital, Wynberg, South Africa
1988 - 1992 Registrar - Ophthalmology, University of Cape Town - Groote Schuur Hospital, South Africa
Fellowship Examination - College of Medicine, South Africa.
1992 - 1995 Consultant - Dept. Ophthalmology, Groote Schuur Hospital and University of Cape Town, South Africa
Consultant - Glaucoma clinic, Retinal clinic, Ocular Tumour clinic, Cape Town, South Africa
1995 – current Private Practice - Claremont, Cape Town, South Africa.
Senior Consultant, Retinal Clinic, Groote Schuur Hospital, South Africa
Subspecialty interests—Vitreoretinal, Diabetes, Ocular Tumors
Participation in clinical trials research in the last three years (title, protocol number, study phase, designation, start and stop dates) [If multiple trials, only list those with relevance to this application, or in the last year.]
Protocol Number: 206207-008
Protocol Title: A Six-Month,Phase 3,Multicenter,Masked,Randomised,Sham-
Controlled Trial (with Six-Month Open-Label Extension) to Assess the Safety and Efficacy of 700ug and 350ug Dexamethasone posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Macular Edema Following Central Retinal Vein Occlusion or Branch Retinal vein Occlusion
Protocol Number: 206207-010
Protocol Title: A 3 Year, Phase 3, Multicenter, Masked, Randomized, Sham Controlled Trial to Assess the Safety and Efficacy of 700 µg and 350 µg Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Diabetic Macular Edema
Protocol Number: 208397-001
Protocol Title: A 12-Month, Multicenter, 2-Stage (Open Label, Dose-Escalation, Followed by Masked,Randomized) Single Dose Study of the Safety and Efficacy of AGN-208397 in Patients with Macular Edema (ME) Associated with Retinal Vein Occlusion (RVO)
Protocol Number: NT-503-SA-11232009-1
Protocol Title A Study to Evaluate the Safety and Feasibility of Vitreous Cavity Implantation of NT-503 for the Treatment of Subfoveal Choroidal Neovascularization (CNV) Secondary to Age Related Macular Degeneration (AMD)Phase II; 2012
Protocol Number: OTX-12-003
A Prospective, Multicenter, Randomized, Double-Masked, Mult-arm
Phase II Study Evaluating the Safety and Efficacy of OTX Compar-
ed to Timolol Drops in the Treatment of Subjects with Open-Angle
Glaucoma or Ocular Hypertension.
Peer-reviewed publications in the past 3 years:
1) Co-author of 2 articles on Glaucoma.
2) “Fatal air embolism during endoresection of choroidal melanoma”. Retinal cases. CABR 213-1091. James Rice et al.
3) “Brachytherapy and Endoresection for Choroidal Melanoma. A cohort study. BJOphthalmol-2013-304006.R1. James Rice et al. Online open access.
Any additional relevant information supporting abilities to participate in conducting this trial. [Briefly]
1999 : Secretary Ophthalmological Society of South Africa
Western Cape Region, OSSA Congress Cape Town
2000-2010 : Director, Peninsula Eye Clinic, Claremont, South Africa
Provincial Eye Care Advisory Committee Member, South Africa
2005-2006 : Executive Committee, Newlands Surgical Clinic, Claremont, South Africa
2008-current : Director Peninsula Eye Hospital and Lifecare Ophthalmology, South Africa
Sep 2010 : Attended EUretina Congress – Paris, France
March 2011 : Antwerp Vitreoretinal course
Sep 2012 : Attended EUretina Congress – Milan, Italy
Papers presented at OSSA Congresses:
• "Optic Neuritis, M.R.I. and Steroids "
• "Optic Canal Fractures”
• “Complications of Mitomycin C Trabeculectomies “
Additional professional activities:
• 1998, 1999: Secretary and Treasurer, OSSA Western Cape, South Africa
• 1999: Committee member, OSSA Congress, Cape Town, South Africa
• Bureau for Prevention of Blindness tours
• Organizing Committee Gonin Club Meeting, Cape Town, 2006
• Ophthalmological Society S.A. (OSSA)
• Vitreoretinal Society S.A.
• Glaucoma Society S.A.
• South African Private Practitioners Forum
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