Suprachoroidal CLS-TA With Intravitreal Aflibercept Versus Aflibercept Alone in Subject With Diabetic Macular Edema

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Macular Edema

In brief

The purpose of this trial is to evaluate the safety and efficacy of suprachoroidal CLS-TA used with intravitreal aflibercept in subjects with DME.

Key facts

Study ID

NCT03126786

Run by

Clearside Biomedical, Inc.

People needed

71

Starts

2017-07-11

Expected to finish

2018-04-17

Last updated by the study team

2021-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 or type 2 DM
• DME with central involvement (> 300 µm in the central subfield on spectral-domain optical coherence tomography [SD-OCT], in the study eye
• ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
• Naïve to local pharmacologic treatment for DME in the study eye

You may not qualify if…

• 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
• Any previous treatment in the study eye with an ocular corticosteroid implant
• Has significant media opacity precluding evaluation of retina and vitreous in the study eye.
• History of glaucoma or optic nerve head change consistent with glaucoma damage
• History of glaucoma surgery
• History of clinically significant IOP elevation in response to corticosteroid treatment ("steroid responder")

Where it is running

• Retinal Consultants of Arizona and Retinal Research Institute — Phoenix, Arizona, United States
• Retina Centers, PC — Tucson, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina Vitreous Medical Group Clinical Research — Beverly Hills, California, United States
• Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States
• Retina Institute of California — Palm Desert, California, United States
• Retina Consultants San Diego — Poway, California, United States
• MedEye Associates — Miami, Florida, United States
• Retina Specialty Institute — Pensacola, Florida, United States
• Sarasota Retina Institute — Sarasota, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Emory Eye Center — Augusta, Georgia, United States
• Marietta Eye Clinic — Marietta, Georgia, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Retina and Vitrous Associates of Kentucky — Lexington, Kentucky, United States
• The Johns Hopkins Wilmer Eye Institute — Baltimore, Maryland, United States
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Retina Associates of NJ — Teaneck, New Jersey, United States
• Western Carolina Retinal Associates — Asheville, North Carolina, United States
• Oregon Retina Institute — Medford, Oregon, United States
• Black Hills Regional Eye Institute — Rapid City, South Dakota, United States
• Retina Research Institute of Texas — Abilene, Texas, United States
• Texas Retina Associates-Arlington — Arlington, Texas, United States
• Austin Retina Associates — Austin, Texas, United States
• Texas Retina Associates — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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