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

NCT02555306 | Completed Phase 1 Results

• 1 other identifier: 36-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

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).

Conditions

Age-Related Macular Degeneration

Keywords

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) at 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.

  Baseline (Day1) and Day 90.

Secondary Outcomes (1)

• Change From Baseline in Central Subfield Thickness (CST) at Day 90.

  Baseline (Day1) and Day 90.

Study Arms (4)

Low Dose DE-122

EXPERIMENTAL

Single intravitreal injection of DE-122 Low Dose Injectable Solution

Drug: 0.5 mg of DE-122

Medium-Low Dose DE-122

EXPERIMENTAL

Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution

Drug: 1.0 mg of DE-122

Medium-High Dose DE-122

EXPERIMENTAL

Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution

Drug: 2.0 mg of DE-122

High Dose DE-122

EXPERIMENTAL

Single intravitreal injection of DE-122 High Dose Injectable Solution

Drug: 4.0 mg of DE-122

Interventions

0.5 mg of DE-122 DRUG

DE-122 Injectable Solution

Low Dose DE-122

1.0 mg of DE-122 DRUG

DE-122 Injectable Solution

Medium-Low Dose DE-122

2.0 mg of DE-122 DRUG

DE-122 Injectable Solution

Medium-High Dose DE-122

4.0 mg of DE-122 DRUG

DE-122 Injectable Solution

High Dose DE-122

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen Inc.: lead

Study Sites (5)

Unknown Facility

Mountain View, California, 94040, United States

Location

Unknown Facility

Walnut Creek, California, 94598, United States

Location

Unknown Facility

Jackson, Michigan, 49202, United States

Location

Unknown Facility

Austin, Texas, 78705, United States

Location

Unknown Facility

McAllen, Texas, 78503, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

carotuximab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Results Point of Contact

• Title: R&D Quality Manager
• Organization: Santen Inc

evelyn.chikere@santen.com

+1 415 268 9199

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: September 21, 2015
• Study Start: September 16, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: January 14, 2020
• Results First Posted: January 14, 2020

Record last verified: 2020-01

Locations

US (5)