Study of suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Retinal Vein Occlusion

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/11/010451
• Date of registration: 10-11-2017
• Prospective Registration: Yes
• Primary sponsor: Clearside Biomedical Inc
• Public title: Study of suprachoroidal CLS-TA with Intravitreal Aflibercept in Subjects with Retinal Vein Occlusion
• Scientific title: 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
• Date of first enrolment: 12-02-2018
• Target sample size: 460
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19460
• Study type: Interventional
• Study design: Randomized, Parallel Group Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Canada, Czech Republic, Denmark, Germany, Hungary, India, Israel, Italy, Other, Philippines, Poland, Portugal, Slovakia, Spain, Taiwan, United Kingdom, United States of America

Contacts

• Name: Dr Saurendra Das
• Affiliation: Excel Life Sciences Pvt Ltd

• Name: Dr Saurendra Das
• Affiliation: Excel Life Sciences Pvt Ltd

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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 Investigatorâ??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 (â??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 po

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: H348- Other retinal vascular occlusions

Intervention(s)

Intervention1: Active Arm: IVT aflibercept (2 mg/0.05 mL) + SC CLS-TA (4 mg/100 micro litre)
Intervention2: Control Arm: IVT aflibercept (2 mg/0.05 mL) + sham SC procedure
Intervention3: CLS-TA: SupraChoroidal CLS-TA (4 mg/100 micro litre) once in 3 months

Control Intervention1: Aflibercept: IntraVitral aflibercept (2 mg/0.05 mL)once a month

Primary Outcome(s)

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 BaselineTimepoint: Baseline to 8 weeks

Secondary Outcome(s)

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 thicknessTimepoint: Baseline to 24 weeks

Secondary ID(s)

CLS1003-301 Amendment 1 31 Mar 2017

Source(s) of Monetary Support

Clearside Biomedical, Inc., 900 North Point Parkway, Suite 200 Alpharetta, GA 30005, USA

Ethics review

Status: Approved
Approval date: 12/09/2017
Contact:

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

Status: Approved
Approval date: 07/12/2017
Contact:

Institute Ethics Committee, All India Institute of Medical Sciences, Ansari Nagar, New Delhi -110029, India

Status: Approved
Approval date: 14/12/2017
Contact:

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

Status: Approved
Approval date: 22/12/2017
Contact:

B.J. Medical College & Civil Hospital, Ahmedabad-380016, India

Status: Approved
Approval date: 27/12/2017
Contact:

Institutional Ethics Committee situated at Disha Eye Hospital Pvt Ltd 88 (63A) Ghosh Para road Barrackpore Kolkata-700120, West bengal, India

Status: Approved
Approval date: 20/01/2018
Contact:

Institutional Ethics Committee Aravind Medical Research Foundation, 1, Anna Nagar, Madurai-625 020, Tamil Nadu

Status: Approved
Approval date: 27/03/2018
Contact:

Dr. Shroffs Charity Eye Hospital Ethics Committee at Dr. Shroffs Charity eye hospital 5027 Kedar nath Road Daryaganj New Delhi-11002

Status: Approved
Approval date: 27/03/2018
Contact:

Ethics Committee situated at Shroff eye hospital 2nd Floor 222 SV Road near Suburbia Movie theatre bandra West Mumbai- 400050, Maharashtra, India

Status: Approved
Approval date: 07/04/2018
Contact:

Institutional Ethics Committee, PBMS H.V Desai Eye Hospital, S.No.93 Taravade Vasti, Mohammadwadi, Hadapsar Pune-411060 Maharashtra, India

Status: Approved
Approval date: 11/04/2018
Contact:

Institutional Ethics Committee,Indira Gandhi Institue of Medical Sciences IGMS Sheikhpura Patna-800014 Bihar India

Results

• Date Completed: 12/12/2018