Clinical trial NCT02348359: X-82 to Treat Age-related Macular Degeneration
Official title: A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration (AMD)
Macular Degeneration
Exudative Age-related Macular Degeneration
AMD
Macular Degeneration, Age-related, 10
Eye Diseases
Retinal Degeneration
Retinal Diseases
Keywords: Vascular Endothelial Growth Factor (VEGF)
Platelet Derived Growth Factor (PDGF)
AMD
Lead sponsor: Tyrogenex
Sponsor class: INDUSTRY
Collaborators: name: SynteractHCR
name: International Drug Development Institute
First posted: 2015-01-28
Enrollment: 157
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of vision loss due to wet AMD.

Detailed description: Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:

* X-82 50 mg plus ivt anti-VEGF prn
* X-82 100 mg plus ivt anti-VEGF prn
* X-82 200 mg plus ivt anti-VEGF prn
* Placebo plus ivt anti-VEGF prn

Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.

Primary Efficacy Outcome:

The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks after randomization.

Safety Outcomes:

Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse events and serious adverse events.

Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose group).

Eligibility criteria: Inclusion Criteria:

* Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in one or both eyes for at least 6 months prior to joining the study and has required at least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater than 6 weeks for the past two injections in the eye that is selected to be the study eye.
* Must have demonstrated a reduction in macular fluid or macular thickness in the study eye 14 days following an anti-VEGF injection at Screening Visit 1
* Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25 letters (20/320) or better in both eyes

Exclusion Criteria:

* Previous vitrectomy to the study eye within 30 days of Screening Visit 1
* Choroidal neovascularization (CNV) due to causes other than AMD
* Proliferative diabetic retinopathy in either eye

Primary outcomes:
measure: Mean Change in Visual Acuity Score From Day -1 to Week52
timeFrame: Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Beverly Hills
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Redlands
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Golden
country: United States
state: Colorado
city: New London
country: United States
state: Connecticut
city: Fort Myers
country: United States
state: Florida
city: Lakeland
country: United States
state: Florida
city: Melbourne
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Palm Beach Gardens
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Lemont
country: United States
state: Illinois
city: Oak Forest
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Glen Burnie
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Portsmouth
country: United States
state: New Hampshire
city: Bloomfield
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Youngstown
country: United States
state: Ohio
city: Nashville
country: United States
state: Tennessee
city: Abilene
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: The Woodlands
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Study PI
name: Daniel E Salazar, PhD
role: PRINCIPAL_INVESTIGATOR
References: