CTRI/2017/11/010451 [Registered on: 10/11/2017] Trial Registered Prospectively
Last Modified On:
04/04/2019
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
Study of suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Retinal Vein Occlusion
Scientific Title of Study
SAPPHIRE: A randomized, Masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with Intravitreal Aflibercept in Subjects with Retinal Vein Occlusion
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
CLS1003-301 Amendment 1 31 Mar 2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Excel Life Sciences Pvt. Ltd, Assotech Business Cresterra, Tower-2, 9th Floor, Unit-909-913, Plot No.22, Sector-135, NOIDA
201301
India
Gautam Buddha Nagar UTTAR PRADESH 201301 India
Phone
01206280200
Fax
01206280200
Email
sauren@excellifesciences.com
Source of Monetary or Material Support
Clearside Biomedical, Inc., 900 North Point Parkway, Suite 200
Alpharetta, GA 30005, USA
Primary Sponsor
Name
Clearside Biomedical Inc
Address
900 North Point Parkway, Suite 200
Alpharetta, GA 30005, USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Australia Canada Czech Republic Germany Hungary India Israel Italy Philippines Slovakia Spain Taiwan United Kingdom United States of America Austria Denmark Poland Portugal Other
B.J. Medical College & Civil Hospital, Ahmedabad-380016, India
Approved
Dr. Shroffs Charity Eye Hospital Ethics Committee at Dr. Shroffs Charity eye hospital 5027 Kedar nath Road Daryaganj New Delhi-11002
Approved
Ethics Committee Situated at L. V. Prasad Eye institute Kallam Anji Reddy Campus L. V. Prasad marg, Road No. 2 Banjara Hills Hyderabad-500034, India
Approved
Ethics Committee situated at Shroff eye hospital 2nd Floor 222 SV Road near Suburbia Movie theatre bandra West Mumbai- 400050, Maharashtra, India
Approved
Institute Ethics Committee, All India Institute of Medical Sciences, Ansari Nagar, New Delhi -110029, India
Approved
Institutional Ethics Committee Aravind Medical Research Foundation, 1, Anna Nagar, Madurai-625 020, Tamil Nadu
Approved
Institutional Ethics Committee of Topiwala National Medical College and BYL Nair Charitable Hospital G Building Ground Floor, Dr A.L Nair Road, Mumbai Central ,Mumbai-400008
Approved
Institutional Ethics Committee situated at Disha Eye Hospital Pvt Ltd 88 (63A) Ghosh Para road Barrackpore Kolkata-700120, West bengal, India
IntraVitral aflibercept (2 mg/0.05 mL)once a month
Intervention
CLS-TA
SupraChoroidal CLS-TA (4 mg/100 micro litre) once in 3 months
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Has a clinical diagnosis of RVO in the study eye within less than or equal to 9 months screening;
2. Has a CST of greater than or equal to 300 micro metre in the study eye as measured by spectral-domain optical
coherence tomography (SD-OCT) with or without intraretinal or subretinal fluid and
confirmed by the central reading center (CRC);
3. Has an ETDRS BCVA score of greater than or equal to 20 letters read and less than or equal to 70 letters read in the study eye;
4. Is naïve to local pharmacologic treatment for RVO in the study eye;
5. Is at least 18 years of age, understands the language of the informed consent and is willing and able to provide written informed consent before any study procedures, and is willing to comply with the instructions and attend all scheduled study visits.
ExclusionCriteria
Details
1. Has ME with etiology other than RVO;
2. Has, in the study eye, used any topical ocular corticosteroid in the 10 days before
treatment at Visit 2 (Day 0); has at any time received any intraocular or periocular corticosteroid injection, an OZURDEX® implant, a RETISERT® implant, or an ILUVIEN® implant;
3. Has evidence of or history of any ophthalmic condition in the study eye that may have an
associated neovascularization or edema component including, but not limited to,
age-related macular degeneration (AMD), diabetic retinopathy, diabetic macular edema
(DME), retinal detachment, central serous chorioretinopathy, scleritis, optic neuropathy,
or retinitis pigmentosa;
4. Has a history of rubeosis irides or other neovascularization in the study eye; any active
vitreous hemorrhage in the study eye within the last 90 days;
5. Has a history of any vitreoretinal surgery (scleral buckle placement, pars plana
vitrectomy, retrieval of dropped nucleus or intraocular lens, sheathotomy) ever in the
study eye or any ocular surgery in the 3 months before randomization. Prior cataract extraction or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy is allowed but must have been performed at least 3 months before Visit 2 (Day 0);
6. Has a history of an ocular procedure or condition in the study eye within the 3 months
before randomization that, in the Investigator’s opinion, could compromise globe or retinal integrity (eg, staphyloma, high myopia, predisposition to scleral thinning);
7. An ocular condition in the study eye that, in the opinion of the Investigator, would put the subject at risk due to study treatment or procedures (eg, active ocular infection, history of a SC hemorrhage, chalazion, significant blepharitis);
8. Has scarring from laser photocoagulation in the study eye that would compromise visual
acuity;
9. Has had more than 3 macular laser photocoagulation treatments; or has had photocoagulation or cryotherapy in the study eye within the 6 months before Visit 2 (Day 0);
10. Has significant media opacity precluding evaluation of retina and vitreous in the study
eye. This includes cataract that is felt to be a major contributor to reduced visual acuity
and/or likely to undergo surgical repair within 3 months of randomization;
11. History of glaucoma, optic nerve head change consistent with glaucoma damage; or
ocular hypertension in the study eye requiring more than one medication;
12. Has a IOP > 21 mmHg in the study eye at Visit 1 (Day -30 to -1); subjects are not
excluded if IOP is < 22 mmHg in the study eye with no more than 1 IOP-lowering
medication as long as there is no history of glaucoma and the subject has a normal optic
nerve and no evidence of visual field loss;
13. Has a history of glaucoma surgery (filtration surgery/trabeculectomy or tube shunt) in the study eye; has a history of laser trabeculoplasty or MIGs surgery in the study eye;
14. Has a history of clinically significant IOP elevation in response to corticosteroid
treatment (“steroid responderâ€);
General Exclusion Criteria
Individuals are ineligible for participation in this study if he/she meet the following criteria:
15. Is a female subject who is pregnant, lactating or planning a pregnancy or is a female subject of childbearing potential who does not agree to submit to a pregnancy test at
Screening; Females of childbearing potential must agree to use an acceptable method of
contraception throughout participation in the study. Acceptable methods of contraception
include double barrier methods (condom with spermicide or diaphragm with spermicide),
hormonal methods (oral contraceptives; implantable, transdermal, or injectable
contraceptives), or an intrauterine contraceptive device with a documented failure rate of less than 1% per year. Abstinence may be considered an acceptable method of
contraception at the discretion of the Investigator, but the subject must agree to use one of the acceptable birth control methods if she becomes sexually active;
16. Has any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study (eg, infection, uncontrolled elevated blood pressure,cardiovascular disease, poor glycemic control) or put the subject at risk due to study treatment or procedures; NOTE: Uncontrolled BP at screening may be treated before Visit 2;
17. Has a myocardial infarction or stroke within 90 days of treatment;
18. Has a likely need for hospitalization or surgery within the study period, including planned elective surgery or hospitalization;
19. Has a known hypersensitivity to any component of the formulation of TA,aflibercept,
fluorescein, topical anesthetics, or the antiseptic used to prepare the eye for injection according to the Investigator’s standard practice;
20. Is currently enrolled in an investigational drug or device study or has used an
investigational drug within 30 days of entry into this study or participated in an ocular
device study in the last 90 days.
21. History of any inflammatory or other medical condition that the investigator might
reasonably anticipate will require treatment with high-dose corticosteroids (more than
10mg/day oral prednisone or the equivalent) for more than 14 days.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
To demonstrate that suprachoroidal (SC) CLS-TA administered in conjunction with intravitreal
(IVT) aflibercept is superior to IVT aflibercept alone in the proportion of subjects demonstrating more than or equal to 15 letters improvement in best corrected visual acuity (BCVA) two months after Baseline
Baseline to 8 weeks
Secondary Outcome
Outcome
TimePoints
1 To determine the effect of SC CLS-TA administered in conjunction with IVT aflibercept on mean
change from Baseline in BCVA
2 To determine the effect of SC CLS-TA administered in conjunction with IVT aflibercept on mean
change from Baseline in central subfield thickness
Baseline to 24 weeks
Target Sample Size
Total Sample Size="460" Sample Size from India="65" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Patel SR, Targeted administration into the suprachoroidal space using a microneedle for drug delivery to the posterior segment of the eye, Invest Ophthalmol Vis Sci. 2012 Jul 1;53(8):4433-41
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
This is a randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal CLS-TA in conjunction with intravitreal aflibercept in subjects with retinal vein occlusion. The quaified subjects will be divided into two groups. Active group will receive IVT Aflibercept + CLS-TA
Control group will receive IVT Aflibercept + CLS-TA Sham