Health Condition 1: H348- Other retinal vascular occlusions
Conditions
Interventions
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: Supra
Sponsors
Clearside Biomedical Inc
Eligibility
Inclusion 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
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
Public ContactDr Saurendra Das
Excel Life Sciences Pvt Ltd
Outcome results
None listed