state board of optometry 2450 del paso … · 1/10/2017 · 2 form ce-01, rev. 2/16 . ... • ivt...
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BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY EDMUND G. BROWN JR., GOVERNOR
STATE BOARD OF OPTOMETRY 2450 DEL PASO ROAD, SUITE 105, SACRAMENTO, CA 95834 P (916) 575-7170 F (916) 575-7292 www.optometry .ca.gov
Continuing Education Course Approval Checklist
Title: Safety and Efficacy of DARP in Patients with Neovascular AMD
Provider Name: Pacific Eye Associates c/o Cynthia Lieu
Completed Application Open to all optometrists? Yes No Maintain record agreement? Yes No
Detailed Course Description PowerPoint and/or other presentation materials Advertising (optional) CV for EACH course instructor License Verification for each course instructor
Disciplinary History? Yes No
www.optometry
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BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY GOVERNOR EDMUND G. BROWN JR.
0 STATE BOARD OF OPTOMETRY 2450 DEL PASO ROAD, SUITE 105, SACRAMENTO, CA 95834 P (916) 575-7170 F (916) 575-7292 www.optometry.ca.gov
OPTOMETRY
CONTINUING EDUCATION COURSE APPROVAL
$50 Mandatory Fee ! APPLICATION
Pursuant to California Code of Regulations (CCR) 1536, the Board will approve continuing education (CE) courses after receiving the applicable fee, the requested information below and it has been determined that the course meets criteria specified in CCR 1536(9).
In addition to the information requested below, please attach a copy of the course schedule, a detailed course outline and presentation materials (e.g., PowerPoint presentation). Applications must be submitted 45 days prior to the course presentation date. Please type or print clearly. Course Title Course Presentation Date
Safety and Efficacy of DARPin in Patients with
Ne..ov (}.
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1
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BUSINESS, CONSUMER SERVICES, AND HOUSING AGENCY
,. ,ff\\... . STATE BOARD OF OPTOMETRY ,\ ~ ... 2450,DEl!J~AQ.i;{,OAD, SUITE 105, SACRAMENTO, CA 95834~---e ""''""'"'"""'""''" ::\7 P (916) 575-7170 F (916) 575-7292 WWW.optometry.ca.gov
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GOVERNOR EDMUND G. BROWN JR.
CONTINUINGEt.>'UCATION COURSE APPROVAL
I $50 Mandatory j ~~~LIC~:ION ~---- --PursuannoCalifomiaCoaeof Rego1aticfn!f{CCR)"-1536~the Boarc:i-wiu-approve continuing education-(CEtcourses after --~
receiving the applicable fee, the requested information below and it has been determined that the course meets criteria specified in CCR 1536(g).
In addition to the information requested below, please attach a copy of the course schedule and topical outline of the subject matter. Applications must be submitted 45 days prior to the course presentation date.
Please type or print clearly.
Course Title Course Presentation Date
Safety and Efficacy of DARPin in Patients with Neovascular AMO
@] []/@] []/[]@] [] [] Course Provider Contact Information
Provider Name
Ali Zaidi, MD A. '
(First) (Last) (Middle) Provider Mailing Address
2100 Webster St, #214 San Francisco 5 treet City State CA Zip 94115
Provider Email AddressAZAI D l@P AC IF ICEYE,COM
Will the proposed course be open to all California licensed optometrists? DYES l!!lNO
Do you agree to maintain and furnish to the Board and/or attending licensee such records of course content and attendance as the Board requires, for a period of at least three years l!!lYES ONO from the date of course presentation?
Course Instructor Information Please provide the information below and attach the curriculum vitae for each instructor or lecturer involved in the course. If th . t t . the course, p ease prov1"d the reques e t d . f f t heet f paper.ere are more ms rue ors 1n I e in orma 10n on a separa e s o
Instructor Name
Ali Zaidi, MD A. (First) (Last) (Middle)
License Number A 123024 License Type MD
Phone Number ( 415 ) 923-3007 E . Add AZAIDl@PACIFICEYE.COMma11 ress
I dee/ re under penalty ofperjury under the laws of the State of California that all the information submitted on this fi m-ant1J5n a'\Y accompanying attachments submitted is true and correct.
1 . , l_.,. & b I,~ It~ Signa ure of Course Provider Date
Form CE-01, Rev. 2/16 2
mailto:AZAIDl@PACIFICEYE.COMhttp:WWW.optometry.ca.gov
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Course outline:
Introducing a new treatment option for wet age-related macular degeneration: Abicipar pegol
--Review present treatment --Present the Abicipar molecule --Review phase I and II clinical trial results --Introduce the phase III clinical trial --Review inclusion and exclusion criteria
Course summary:
This presentation will provide an overview of the wet AMD treatment options. It is important to know the limitations of the current drug treatments. We will review a new drug: Abicipar pegol. This drug has shown promising results in phase I and II clinical trials and now a phase III clinical trial is ongoing. Optometrists can identify patients who are candidates for this new therapy and refer them to appropriate places.
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25/07/2016
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DARPins A Potential New Generation of Protein Therapeutics
Abicipar Pegol Recombinant protein of the designed ankyrin repeat protein (DARPin) family
Small molecular weight (34 kDa)1
Highly potent antagonist to VEGF-A isoforms2
1. Data on file. 2. Souied et al, AJO. 2014
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Safety and Efficacy of DARPin(abicipar
pegol) in Patients with
Neovascular AMD
DARPin Abicipar Pegol
The Class The Compound
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25/07/2016
DARPin (Designed Ankyrin Repeat Proteins)
Abicipar s higher binding affinity1 and longer vitreous half life
compared to published data for ranibizumab may produce a longer
dosing interval
Characteristics Abicipar2 Ranibizumab
Molecular weight 34 kDa 48 kDa
Binding affinity (Kd) 0.4 pM 42.5 pM
Half-life (t ) 4-7 days 3 days3
3 1. Data on file, Allergan, Inc.; 2. Data on file, Allergan, Inc.; 3. Ophthalmology. 2007
Nonclinical Efficacy: Inhibition of Vascular Leakage
In a rabbit model of VEGF-induced vasculopathy, an
equimolar dose of abicipar provided superior duration
of action compared to ranibizumab (at 4 weeks)
Vehicle
Ranibizumab
Abicipar
Abicipar may be efficacious in treating patients with neovascular AMD
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25/07/2016
PHASE 2 CLINICAL STUDIES IN
ABICIPAR PEGOL FOR NEOVASCULAR AMD
Phase 1 study of abicipar pegol in neovascular AMD conducted by Molecular Partners (Study MP0112 CP01)
REACH: A Phase 2 Study in Neovascular AMD (nAMD)
Study Country Population Objective
150998-001* Global**
Stage 1 Advanced disease
N = 24 Evaluate safety
Stage 2 Treatment-naive
N = 183 Evaluate effect of single dose
Stage 3 Treatment-naive
N = 64
Evaluate effect of repeat
dosing
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* NCT01397409 **US, Australia, Austria, Switzerland, France, Germany, Israel, Italy
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Stable vision s def ned as < 15 letter oss n ETDRS BCVA
= =
=
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25/07/2016
Completed Phase 2a Clinical Study
NCT01397409* (REACH)
Stage 3, 64 patients received 2mg (N 23), 1mg (N 25)
or ranibizumab (N 16) and followed for 20 weeks
IVT injections at Day 1, weeks 4 and 8 (abicipar) and
also weeks 12 and 16 (ranibizumab only)
Abicipar Pegol 2mg BCVA Letter Gain
Abicipar Pegol 1mg BCVA Letter Gain
Ranibizumab BCVA Letter Gain
Week 16 8.2 6.3 5.3
Week 20 9.0 7.1 4.7
7 * Clinicaltrials.gov and press release (30Jun2014, Allergan)
REACH Stage 3 Effect of Repeat Dosing
Objective: To assess the safety and treatment effects of 3 doses of abicipar every 4 weeks in treatment nave patients with nAMD
Primary Endpoint: Mean change in ETDRS BCVA
Key Additional Efficacy Endpoints: Proportion of patients with 15 letter gain, proportion of patients with stable vision*, change in CRT from baseline
Visit Schedule (week)
Abicipar 1 mg
Abicipar 2 mg
Ranibizumab 0.5 mg N
B 4 8 12 16 20
Primary endpoint
Active treatment
n=64 (3:3:2) Sham treatment
No treatment
Study was not powered to show statistically significant differences between treatment groups 8*
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http:Clinicaltrials.gov
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Abicipar 2.0 mg (n 23)
Abicipar 1.0 mg (n 25)
Ranibizumab 0.5 mg (n 1
25/07/2016
0
2
4
6
8
10
12
Baseline Week 1 Week 4 Week 8 Week 12 Week 16 Week 20
=
=
= 6)
BC
VA
Me
an
Ch
an
ge F
rom
Ba
se
lin
e(L
ett
ers
S
E)
mITT with LOCF
Assessment Visits (week)
REACH Stage 3 Mean Change in BCVA From Baseline
Abicipar 2.0 mg (n = 23)
Abicipar 1.0 mg (n = 25)
Ranibizumab 0.5 mg (n = 16)
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REACH Stage 3 Mean Change in CRT From Baseline
-250
-200
-150
-100
-50
0
Abicipar 2.0 mg (n=23)
Abicipar 1.0 mg (n=25)
Ranibizumab 0.5 mg (n=16)
CR
T M
ea
n C
ha
ng
e (
m
SE
)
Week 1
Week 4
Week 8
Week 12
Week 16
Week 20
Baseline
10 mITT with LOCF
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25/07/2016
REACH Stage 3
Ocular Adverse Events of Special Interest
Number of Patients with Event (%)
Adverse Event Abicipar 2 mg
(N = 23) Abicipar 1 mg
(N =25) Ranibizumab 0.5 mg
(N =16)
Vitreous Detachment 2 (8.7) 2 (8) 0
Eye Pain 2 (8.7) 1 (4) 1 (6.3)
Iritis 1 (4.3) 1 (4) 0
Choroiditis 1 (4.3) 0 0
Vitritis 0 1 (4) 0
Uveitis 0 1 (4) 0
Retinal haemorrhage 0 3 (12) 2 (12.5)
Macular Scar 0 0 2 (12.5)
No Serious Adverse Events were reported
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REACH Stage 3 Summary
Visual acuity improvement was numerically greater than ranibizumab at Week 16 (8 weeks after the final abicipar injection)
This greater numerical difference between treatments was sustained at week 20, 12 weeks after the final abicipar injection
No serious adverse events were observed
Intraocular inflammation occurred in 2 patients treated with abicipar 2mg, 3 patients treated with abicipar 1 mg, none with ranibizumab
Data support current AMD clinical program
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Ongoing Phase 2 Clinical Studies in nAMD*
Objective: To assess the safety and treatment effects of 3 doses of abicipar every 4 weeks in treatment naive patients with nAMD
Primary endpoint: Mean change from baseline ETDRS BCVA Secondary endpoints: CRT, vision gain
Abicipar 1 mg
Abicipar 2 mg
Ranibizumab 0.5 mg
Active treatment
Sham treatment
No treatment
B 4 8 12 16 20
Visit Schedule (week)
Primary endpoint
n=25 (2:2:1)
13 Clinicaltrials.gov NCT02181517 and NCT02181504
PHASE 3 CLINICAL STUDIES IN
ABICIPAR PEGOL FOR NEOVASCULAR AMD
Phase 1 study of abicipar pegol in neovascular AMD conducted by Molecular Partners (Study MP0112 CP01)
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http:Clinicaltrials.gov
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25/07/2016
Phase 3 Study Design
Objective: To assess the safety and efficacy of abicipar pegol compared with ranibizumab in treatment naive patients with neovascular AMD
Primary endpoint: Proportion of patients with stable vision*
Secondary endpoints: Mean change from baseline in ETDRS BCVA, mean change from baseline in CRT, proportion of patients with 15 letter gain, mean change from baseline in NEI VFQ 25 composite score
*Defined as a loss of fewer than 15 letters in ETDRS BCVA compared to baseline
Abicipar pegol 2 mg
Ranibizumab 0.5 mg
Sham treatment
No treatment
n = 900 (1:1:1)
BL 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100
2Q8
2Q12
RQ4
Week
Primary endpoint
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Phase 3 Clinical Studies Key Inclusion Criteria
> 50 years of age
BCVA 73 and 24 letters (20/40 to 20/320 Snellen
equivalents, respectively) in the study eye
Presence of active subfoveal and/or juxtafoveal CNV
secondary to AMD with retinal fluid on OCT and/or
fluorescein leakage under the fovea in study eye
Area of CNV lesion, including both classic and occult
components, must be >50% of the total lesion area in
study eye
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Phase 3 Clinical Studies Key Exclusion Criteria for the Study Eye
Previous use of verteporfin PDT or any ocular
antiangiogenic therapy (eg, aflibercept, bevacizumab,
ranibizumab, pegaptanib), approved or investigational,
for the treatment of neovascular AMD
Any prior or current systemic or ocular treatment
(including surgery) for neovascular AMD, approved or
investigational, except dietary supplements or vitamins
Prior use of ocular anti VEGF agents for neovascular
eye diseases other than AMD
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THANK YOU
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J_
Ali Zaidi, MD 2100 Webster Street, Suite 214, San Francisco CA 94115
Phone: 415-923-3007 E-Mail: azaidi@pacificeye.com
Work Experience
-~ - - ---Retina-surgeon, PacificEye-Associates;-San-Francisco;-CA--~------ - --------~ -- --Mar-2014-
Present
Retinal Surgeon, Retina-Macula Specialists, Tacoma, WA Jan 2014
Teacher, Casablanca American School, Morocco
College Coordinator, Woosh!, Palo Alto
Education
Board Certified, American Board of Ophthalmology
Retina surgery fellowship - Scheie Eye Institute, Philadelphia, PA
Ophthalmology residency - Scheie Eye Institute, Philadelphia, PA
Internship - Cambridge Hospital, Cambridge, MA
Medical School - University of California, San Francisco
Undergraduate - Stanford University, Stanford, CA
Publications
~~--~----
Aug 2011
Aug 2000 -June 2001
June 2000 - Sept 2000
June 2011
July 2009 - June 2011
July 2006 - June 2009
July 2005-July 2006
Sept 2001 -June 2005
Sept 1996 - June 2000
Wehrli, S Tawse, K, Zaidi, et al. A lack of delayed intraocular pressure elevation in patients treated with intravitreal injection of bevacizumab and ranibizumab. Retina 2012; 32(7): 1295-301.
Zaidi AA, Brucker AJ, Johnson MW. Diagnostic and therapeutic challenges: management of macular schisis. Retina 2011; 31(10): 2125-8.
Zaidi A, Ying GS, Kempen JK, et al. Hypopyon in patients with uveitis. Ophthalmology 201 O; 117; 366372.
Zaidi, A, Pistilli M, Brucker AJ. Letter to editor of BJO in response to "Sustained elevation of intraocular pressure after intravitreal injections of anti-VEGF agents" by Good et al. BJO Aug 2010.
Melese M, Alemayehu W, Zaidi A, et al. Comparison of annual and biannual mass antibiotic administration for elimination of infectious trachoma. JAMA 2008; 299(7):778-784.
Zaidi A, Brucker AJ. Management of diabetic macular edema: Are standards changing? Retinal physician. April 2010.
Zaidi A, Alvarado R, Irvine A. Pneumatic retinopexy: success rate and complications. Br J Ophthalmol 2006; 90:427-428.
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mailto:azaidi@pacificeye.com
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l I 'Page 2
i Zaidi A, McLeod s. Laser in situ keratomileusis in a i:>atient with i:>resumed central cloudy corneal I ---------
dystrophy of Francois. Am J Ophthalmol 2005; 139:376-377.
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CE Course Provider Checklist Template (2)Safety and Efficacy of DARP in Patients with Neovascular AMDDr. Zaidi ChecklistSafety and Efficacy of DARP in Patients with Neovascular AMDSafety and Efficacy of DARP in Patients with Neovascular AMDzaidi_ceSafety and Efficacy of DARP in Patients with Neovascular AMDZaidi Course outline
abicipar pegol phase 3 recruitment Final (2)Safety and Efficacy of DARP in Patients with Neovascular AMDSafety and Efficacy of DARP in Patients with Neovascular AMD
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