Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD

Phase 1

Completed

• Conditions: Age-Related Macular Degeneration (AMD)
• Interventions: Drug: PAN-90806 Ophthalmic Solution; Drug: Lucentis

• Registration Number: NCT02022540
• Lead Sponsor: PanOptica, Inc.

Brief Summary

The objective of this study is to assess the safety and tolerability of topical ocular PAN-90806 in patients with active, subfoveal choroidal neovascularization associated with neovascular Age-Related Macular Degeneration (AMD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-20
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-02
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-27
• Last Update Posted: 2016-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis in the study eye of active, pathologic, newly diagnosed and previously untreated, subfoveal choroidal neovascular (CNV) lesions secondary to neovascular AMD
• Aged 50 years or older
• Demonstrate the ability, or have a family member who is willing and able, to instill topical ocular drops in the study eye

Exclusion Criteria

• No prior ocular or systemic treatment or surgery for neovascular AMD in the study eye

• History of or current clinical evidence in the study eye of:

  • aphakia
  • diabetic macular edema
  • any ocular inflammation or infections
  • pathological myopia
  • retinal detachment
  • advanced glaucoma
  • significant media opacity, including cataract

• History or evidence of the following surgeries in the study eye:

  • penetrating keratoplasty or vitrectomy;
  • corneal transplant;
  • corneal or intraocular surgery within 3 months of Screening

• Uncontrolled hypertension despite use of antihypertensive medications

• Participation in any investigational drug or device study, systemic or ocular, within past 3 months

• Women who are pregnant or nursing

• Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 2	Lucentis	Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks
Stage 1 - Group 1	PAN-90806 Ophthalmic Solution	Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1 - Group 5	PAN-90806 Ophthalmic Solution	Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1- Group 4	PAN-90806 Ophthalmic Solution	Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1 - Group 2	PAN-90806 Ophthalmic Solution	Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 1- Group 3	PAN-90806 Ophthalmic Solution	Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.
Stage 2	PAN-90806 Ophthalmic Solution	Patients enrolled in Stage 2 will receive an intravitreal injection of ranibizumab and then 7-9 days later begin daily dosing with PAN-90806 Ophthalmic Solution for 12 weeks

Primary Outcome Measures

Name	Time	Method
Safety	3 months	Presence of any targeted adverse events (TAEs); safety endpoints include adverse events, vital signs, laboratory abnormalities, ophthalmic findings and outcomes