A Phase I/II Safety Study of DE-120 Injectable Solution f... | NCT02022501

NCT02022501

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Dose DE-120	Experimental	Single 20 µL intravitreal injection of Low Dose DE-120 injectable solution	Drug: DE-120
Medium Dose DE-120	Experimental	Single 20 µL intravitreal injection of Medium Dose DE-120 injectable solution	Drug: DE-120
High Dose DE-120	Experimental	Single 20 µL intravitreal injection of High Dose DE-120 injectable solution	Drug: DE-120

Name	Type	Description	Arm Group Labels	Other Names
DE-120	Drug		High Dose DE-120 Low Dose DE-120 Medium Dose DE-120

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of subjects with adverse events	Adverse events will be assessed at each visit to assess safety	Each visit from Day 1 to Study Exit (Month 24)
Change from Baseline in central subfield thickness (CST)	CST will be measured using spectral domain optical coherence tomography (SD-OCT)	Each visit from Day 1 through Study Exit (Month 24)
Change from Baseline in macular volume	Macular volume will be measured using spectral domain optical coherence tomography (SD-OCT)	Each visit from Day 1 through Study Exit (Month 24)
Drug concentration in plasma over time after a single injection of DE-120	Pharmacokinetic assessments will include area under the plasma concentration time curve (AUC), peak plasma concentration (Cmax), time to peak plasma concentration (tmax) and elimination half life (t1/2)	Most visits from Day 1 through Study Exit (Month 24)

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline in ocular signs and symptoms	Ocular signs and ocular symptoms will be collected at each visit using slit lamp biomicroscopy, corrected visual acuity, ophthalmoscopy and intraocular pressure measurements	Each visit from Day 1 through Study Exit (Month 24)

Eligibility Module

Eligibility Criteria

Main Inclusion Criteria:

Understand and provide signed written informed consent
Diagnosis of chronic subretinal or intraretinal fluid secondary to exudative age-related macular degeneration in the study eye
At least one lesion in the study eye that meets minimal pathology criteria
Visual acuity of ≤ 55 ETDRS letter (20/80 Snellen equivalent) or worse in the study eye, excluding No Light Perception
Reasonably clear media and some fixation in the study eye

Main Exclusion Criteria:

Ocular

Visual acuity of No Light Perception
Aphakic or has an anterior chamber intraocular lens in the study eye.
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 glaucoma, chronic hypotony or vitrectomy in the study eye
Evidence of any other ocular disease other than late stage exudative age related macular degeneration in the study eye that may confound the outcome of the study .
Proscribed ocular surgery in the study eye either prior to or during the course of the trial
Presence or history of certain ocular or periocular pathology or conditions that could limit ability to perform required study assessments in either eye and/or confound study results

Non-Ocular

Systemic treatment with anti-VEGF agents (e.g., bevacizumab) is prohibited at any time during the study
Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications.
Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for a clinical trial
Participation in other investigational drug or device clinical trials within 30 days prior to Screening 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

Facility	Status	City	State	ZIP	Country	Contacts
		Bakersfield	California		United States