Pilot Study of X-82 in Patients With Wet AMD

Conditions

• Exudative Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• X-82 oral — DRUG
  X-82 oral for 24 weeks or until unacceptable toxicity develops
• ranibizumab (Lucentis) — DRUG
  Rescue treatment with intravitreal ranibizumab (Lucentis) as needed

Study Details

The objective of this study is to evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD). Preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus photography, fluorescein angiography and optical coherence tomography (OCT).

Key Dates

First listed

Aug 29, 2012

Start date

Oct 31, 2012

Status verified

Jul 2018

Primary completion

Feb 28, 2015

Completion

Feb 28, 2015

Study Design

Enrollment

35 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 50 mg X-82 oral alternate days
  50 mg X-82 oral on alternate days with intravitreous ranibizumab (Lucentis) using predefined retreatment criteria for 24 weeks or until unacceptable toxicity develops
• Experimental: 50 mg X-82 oral QD
  50 mg X-82 oral QD with intravitreous ranibizumab (Lucentis) therapy using predefined retreatment criteria.for 24 weeks or until unacceptable toxicity develops
• Experimental: 100 mg X-82 oral alternate days
  100 mg X-82 oral on alternate days with intravitreous ranibizumab (Lucentis) using predefined retreatment criteria.for 24 weeks or until unacceptable toxicty develops
• Experimental: 100 mg X-82 oral QD
  100 mg X-82 oral QD with intravitreous ranibizumab (Lucentis) using predefined retreatment criteria for 24 weeks or until unacceptable toxicity occurs
• Experimental: 200 mg X-82 oral QD
  200 mg X-82 oral QD with intravitreous ranibizumab (Lucentis) therapy using predefined retreatment criteria for 24 weeks or until unacceptable toxicity occurs
• Experimental: 300 mg X-82 oral QD
  300 mg X-82 oral QD with intravitreous ranibizumab (Lucentis) therapy using predefined retreatment criteria for 24 weeks or until unacceptable toxicity occurs.

Primary Outcome Measure

Change From Baseline Visual Acuity at 6 Months [ Time Frame: 6 months ]

Locations (5)

Find similar trials in Beverly Hills, CA

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