Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA With Intravitreal Anti-VEGF Agent in Subjects With Retinal Vein Occlusion

• suprachoroidal CLS-TA (Drug), also known as Triamcinolone acetonide: suprachoroidal injection of CLS-TA
• suprachoroidal sham (Drug): sham suprachoroidal procedure
• Lucentis or Avastin (Drug), also known as IVT anti-VEGF agent: IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin

Primary outcomes

• Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [2 months]: Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

Secondary outcomes

• Mean Change From Baseline in Best Corrected Visual Acuity [6 months]: Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. A positive change from baseline value represents an improvement in vision.
• Mean Change From Baseline in Central Subfield Thickness [6 months]: Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Has a clinical diagnosis of RVO in the study eye
* Has a CST of ≥ 300 µm in the study eye
* Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye
* Is naïve to local pharmacologic treatment for RVO in the study eye

Exclusion Criteria:

* Any active ocular disease or infection in the study eye other than RVO
* History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication
* Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
* Any evidence of neovascularization in the study eye

Participant flow

Outcome results

• Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) (Primary), Count of participants, Participants: Active 64; Control 76 (p 0.191)
• Mean Change From Baseline in Best Corrected Visual Acuity (Secondary), Least squares mean, letters: Active 13.8 +/- 1.96; Control 20.7 +/- 1.91
• Mean Change From Baseline in Central Subfield Thickness (Secondary), Least squares mean, microns: Active -353.6 +/- 19.60; Control -374.7 +/- 19.12

Adverse events

Time frame: Adverse events were collected through follow-up and study completion, approximately 6 months.

Serious adverse events by term

Other adverse events by term

Limitations and caveats: Due to the early termination of the trial by sponsor, 325 of the planned 460 were enrolled. All planned study visits were not completed by all treated subjects; therefore, all planned data was not collected.

• Study Protocol and Statistical Analysis Plan (PDF, 2018-01-25)

• Thomas Ciulla, MD, Study director, Chief Medical Officer