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

PanOptica

Status and phase: Completed; Phase 1

Conditions: Age-Related Macular Degeneration (AMD)

Treatments: Drug: PAN-90806 Ophthalmic Solution; Drug: Lucentis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02022540

PAN-01-101

Details and patient eligibility

About

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).

Enrollment: 50 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 6 patient groups

Stage 1 - Group 1

Experimental group

Description:

Patients randomized to Group 1 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Treatment:

Drug: PAN-90806 Ophthalmic Solution

Stage 1 - Group 2

Experimental group

Description:

Patients randomized to Group 2 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Treatment:

Drug: PAN-90806 Ophthalmic Solution

Stage 1- Group 3

Experimental group

Description:

Patients randomized to Group 3 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Treatment:

Drug: PAN-90806 Ophthalmic Solution

Stage 1- Group 4

Experimental group

Description:

Patients randomized to Group 4 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Treatment:

Drug: PAN-90806 Ophthalmic Solution

Stage 1 - Group 5

Experimental group

Description:

Patients randomized to Group 5 will receive PAN-90806 Ophthalmic Solution daily for 8 weeks.

Treatment:

Drug: PAN-90806 Ophthalmic Solution

Stage 2

Experimental group

Description:

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

Treatment:

Drug: Lucentis

Drug: PAN-90806 Ophthalmic Solution