This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).
In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg. In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg. In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg. All subjects in the study will receive study treatment in one selected study eye only.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
3 intravitreal injections of THR-687 dose level 1, 1 month apart
3 intravitreal injections of THR-687 dose level 2, 1 month apart
3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Salehi Retina Institute Inc.
Huntington Beach, California, United States
Change From Baseline in BCVA ETDRS Letter Score, at Month 3, in Treatment-naïve Subjects in Part B of the Study
Time frame: At Month 3
Weighted Average of the Change From Baseline in BCVA ETDRS Letter Score From Day 8 Through Month 3 Using the Trapezoidal Rule (AUC), in Treatment-naïve Subjects in Part B of the Study
Time frame: at Month 3
Change From Baseline in BCVA ETDRS Letter Score, by Study Visit, in Treatment-naïve Subjects in Part B of the Study
Time frame: Up to Month 8
Change From Baseline in Central Subfield Thickness (CST), Based on Spectral Domain Optical Coherence Tomography (SD-OCT), as Assessed by the Central Reading Center (CRC), by Study Visit, in Treatment-naïve Subjects in Part B of the Study
Time frame: Up to Month 8
Incidence of Ocular and Non-ocular Adverse Events (AEs) and Serious Adverse Events (SAEs)
Adverse Events will be reported from the date of Informed Consent until End of the Study visit (up to Month 6 in Part A and up to Month 8 in Part B) or at the early study discontinuation visit and will be coded using MedDRA. Adverse Events will be summarized by System Organ Class and Primary Term. Incidence by subject represents at least one occurrence of the Primary Term with an onset on or after the date of the first study treatment. If a subject has multiple occurrences of an adverse event (P-term), the subject is presented only once in the respective subject count.
Time frame: Up to End of Study (Part A up to Month 6 and Part B up to Month 8)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
California Eye Specialists Medical Group, Inc.
Pasadena, California, United States
Retinal Consultants Medical Group
Sacramento, California, United States
Retina Consultants of Southern Colorado, P.C.
Colorado Springs, Colorado, United States
Retina Associates, Ltd
Elmhurst, Illinois, United States
University Retina and macula Associates, PC
Oak Forest, Illinois, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
...and 15 more locations