A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration

Phase 1

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Drug: 0.5 mg of DE-122; Drug: 2.0 mg of DE-122; Drug: 1.0 mg of DE-122; Drug: 4.0 mg of DE-122

• Registration Number: NCT02555306
• Lead Sponsor: Santen Inc.

Brief Summary

The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-13
• Study Start: 2015-09-16
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-21
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2019-10-11
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-10
• Last Update Submitted: 2020-01-10
• Results First Posted: 2020-01-14
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Provide signed written informed consent
• Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration
• Prior treatment in the study eye with any intravitreal anti-VEGF medication
• At least one lesion in the study eye that meets minimal pathology criteria
• Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye
• Best corrected visual acuity of 20/200 or better in the fellow eye
• Reasonably clear media and some fixation in the study eye

Exclusion Criteria

Ocular

• Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1
• Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye
• Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study
• Need for ocular surgery in the study eye during the course of the study
• Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results

Non-Ocular

• Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications
• Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study
• Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study
• Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study
• Unable to comply with study procedures or follow-up visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Dose DE-122	0.5 mg of DE-122	Single intravitreal injection of DE-122 Low Dose Injectable Solution
Medium-High Dose DE-122	2.0 mg of DE-122	Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution
Medium-Low Dose DE-122	1.0 mg of DE-122	Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution
High Dose DE-122	4.0 mg of DE-122	Single intravitreal injection of DE-122 High Dose Injectable Solution

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.	Baseline (Day1) and Day 90.	BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \[0, 97\] in ETDRS letters.; An increase in BCVA indicates an improvement in the best corrected vision.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Central Subfield Thickness (CST) at Day 90.	Baseline (Day1) and Day 90.	Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.