4D-150 in Patients With Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

Official title:

A Phase 2 Randomized, Active-Controlled, Double-masked Trial of Intravitreal 4D-150 Gene Therapy in Adults With Diabetic Macular Edema (SPECTRA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930561
• Other study ID #: 4D-150-C002
• Status: Recruiting
• Phase: Phase 2
• Start date: August 9, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: November 2023
• Source: 4D Molecular Therapeutics
• Contact: 4DMT Patient Advocacy
• Phone: (888) 748-8881
• Email: clinicaltrials[@]4DMT.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

Description:

This Phase 2 trial is a prospective, multicenter, randomized, active-controlled, double-masked dose-ranging trial to evaluate the safety and efficacy of 4D-150 in adults with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: July 1, 2028
• Est. primary completion date: February 29, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =18 years of age

• Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea; diagnosis of DME must be within 2 years of Screening

• Demonstrate clinical response to on-study aflibercept injection in the study eye.

• Decreased visual acuity attributable primarily to DME

• BCVA in the study eye between 25 and 83 ETDRS letters, inclusive (~20/320 and 20/25, respectively) at Screening

• Study eye amenable to IVT injection

• Sufficient clear ocular media, pupil dilation and fixation in the study eye to permit adequate imaging; ability to perform tests of visual and retinal function and structure; and ability to comply with other protocol-specified procedures

• Provide written informed consent

Exclusion Criteria:

• Macular edema in the study eye considered to be secondary to a cause other than DME

• Systemic anti-VEGF treatment (e.g. sunitinib, bevacizumab, pazopanib) within 6 months, or anticipated need for systemic anti-VEGF therapy during study participation

• Systemic corticosteroids (oral, intravenous, intramuscular, intra-articular) or other immunosuppressive medications within 3 months

• Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to 4D-150 administration (Day 1)

• Prior gene therapy (ocular or non-ocular) and/or ocular stem cell therapy in either eye

• Any concurrent ocular condition in the study eye that is likely to require surgical intervention (e.g. cataract surgery) during the 2 year (104 week) study duration

Note: Other inclusion/exclusion criteria apply.

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Macular Edema

Intervention

Biological:
• 4D-150 IVT
4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept.
• Aflibercept IVT
Commercially available Active Comparator

Locations

Country	Name	City	State
Puerto Rico	Emanuelli Research and Development Center	Arecibo
United States	Vision Research Center Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Western Carolina Retinal Associates	Asheville	North Carolina
United States	Austin Clinical Research	Austin	Texas
United States	Raj K Maturi MD PC	Carmel	Indiana
United States	Retina Consultants of Southern Colorado	Colorado Springs	Colorado
United States	Erie Retina Research	Erie	Pennsylvania
United States	Verum Research, LLC	Eugene	Oregon
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Retina Specialty Institute	Pensacola	Florida
United States	Retinal Research Institute LLC	Phoenix	Arizona
United States	Sierra Eye Associates	Reno	Nevada
United States	Retina Vitreous Associates of FL	Saint Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
4D Molecular Therapeutics

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence and severity of treatment-emergent adverse events and serious adverse events, including clinically significant changes in safety parameters		104 weeks
Primary	Annualized number of aflibercept injections in the study eye		52 weeks
Secondary	Mean cumulative number of aflibercept injections over time		52 weeks
Secondary	Change from baseline in BCVA as assessed using the ETDRS Visual Acuity Chart		104 weeks
Secondary	Change from baseline in CST measured by spectral domain optical coherence tomography (SD-OCT)		104 weeks
Secondary	Percentage of subjects with a =2 and =3-Step Diabetic Retinopathy Severity (DRS) improvement from baseline on the ETDRS-DRSS		104 weeks