Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema

NCT02949024 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CLS1004-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to demonstrate the safety and tolerability of suprachoroidal CLS-TA alone or in combination with intravitreal aflibercept in subjects with diabetic macular edema associated with diabetes mellitus.

Conditions

Diabetic Macular Edema

Keywords

Diabetes mellitus; Diabetic retinopathy; Microneedle; Microinjection; Triamcinolone; Choroid; Choroid Injection; Aflibercept; Suprachoroidal; Triamcinolone acetonide

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

  Number of participants with treatment emergent adverse events and serious adverse events reported over 6 months of follow-up

  Over 6 months of follow-up

Secondary Outcomes (4)

• Mean Change From Baseline in Intraocular Pressure

  Baseline and 6 months

• Mean Change From Baseline in Central Subfield Thickness

  Baseline and 6 months

• Best Corrected Visual Acuity

  Baseline and 6 months

• CLS-TA Injections

  2 to 6 months following initial treatment with study drug

Study Arms (2)

TX Naïve Arm

EXPERIMENTAL

Treatment in the TX Naive arm will consist of one unilateral injection of IVT aflibercept in combination with one unilateral injection of SC CLS-TA in the same eye.

Drug: IVT Aflibercept; Drug: SC CLS-TA

Previous TX Arm

EXPERIMENTAL

Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.

Drug: SC CLS-TA

Interventions

IVT Aflibercept DRUG

IVT aflibercept \[2 mg (50 µL)\]

Also known as: Aflibercept

TX Naïve Arm

SC CLS-TA DRUG

\[4 mg (100 µL)\]

Also known as: Triamcinolone Acetonide

Previous TX Arm; TX Naïve Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
• DME with central involvement (\>320 microns in the central subfield on SD-OCT) in the study eye
• ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye

You may not qualify if:

• Evidence of DME due to any other cause other than diabetes mellitus in the study eye
• PRP or focal laser photocoagulation in the study eye within 90 days of screening
• Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
• History of any previous ophthalmic surgeries in the study eye within 90 days of screening
• High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
• Any previous treatment in the study eye with ILUVIEN implant
• Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion
• Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)
• Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)

Sponsors & Collaborators

• Clearside Biomedical, Inc.: lead

Study Sites (2)

Retina Vitreous Associates Medical Group Inc

Mountain View, California, 94040, United States

Location

Retina Consultants of Houston, PA

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Interventions

aflibercept; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Thomas Ciulla, MD MBA
• Organization: Clearside Biomedical, Inc.

thomas.ciulla@clearsidebio.com

(678) 392-2318

Study Officials

• Thomas Ciulla, MD MBA

  Clearside Biomedical, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: October 31, 2016
• Study Start: November 10, 2016
• Primary Completion: October 17, 2017
• Study Completion: October 17, 2017
• Last Updated: May 13, 2021
• Results First Posted: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)