subjects with retinal vein occlusion

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 15 letter improvement in best corrected visual acuity (BCVA) two months after Baseline

CLS-TA

CLS-TA

injection

40mg/mL with 0.9mL fill vial

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 15 letter improvement in best corrected visual acuity (BCVA) two months after Baseline

1. Has a clinical diagnosis of RVO in the study eye within ≤ 9 months screening;
2. Has a CST of ≥ 300 µm 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 ≥ 20 letters read and ≤ 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

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 >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;