Phase I/II study of PAN-90806 in Patients with AMD
Research type
Research Study
Full title
A Randomized, Double Masked, Uncontrolled, Multicenter Phase I/II Study to Evaluate Safety and Tolerability of PAN-90806 Eye Drops, Suspension in Treatment-Naïve Participants with Neovascular Age-Related Macular Degeneration (AMD)
IRAS ID
245936
Contact name
Kristine Curtiss
Contact email
Sponsor organisation
PanOptica, Inc.
Eudract number
2016-004601-14
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
120693, IND
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
The eye condition called neovascular age-related macular degeneration (AMD) is the most common cause of irreversible vision loss in people aged 50 years or older. Several therapies, administered through intravitreal injections, are already approved for the condition. This study is a double-masked, multi-center study to evaluate the safety, tolerability, and biological response of PAN-90806 Eye Drops in treatment-naïve patients with active, choroidal neovascularisation (CNV), which is the abnormal growth of blood vessels in the eye associated with AMD.
The primary objectives of this study are to assess the safety and tolerability of PAN-90806 Eye-Drops, and secondarily to assess any biological responses to treatment in approximately 60 adults. Biological response will be assessed by changes in vision, changes to the center of the retina, and need for rescue therapy.
Adults, aged 50 years or older, of any race and either sex with an eye newly diagnosed with CNV lesions secondary to neovascular AMD will be screened for inclusion into the study after providing written informed consent.
Participants who are eligible for the study will be randomized (1:1:1) at Day 1 to one of three doses of PAN-90806 Eye Drops administered once daily for 12 weeks: 2 mg/mL, 6 mg/ mL, or 10 mg/mL. The study is masked, which means that neither the participant nor the study doctor will know to which dose the participant has been assigned.
During the treatment period, participants will return for follow-up visits at Week 2, Week 4, Week 8, and Week 12. Then they will return for visits 1 week and 1 month after completion of treatment. Telephone contacts will be performed at Week 6 and Week 10 to assess participant’s well-being.
Participants meeting the study’s criteria of worsening AMD, will be eligible for rescue therapy with ranibizumab, one of the approved drugs for AMD.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/0782
Date of REC Opinion
26 Jun 2018
REC opinion
Further Information Favourable Opinion