Study of PAN-90806 Eye Drops, Suspension for Neovascular AMD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03479372 |
Recruitment Status :
Completed
First Posted : March 27, 2018
Last Update Posted : July 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Neovascular Age-related Macular Degeneration | Drug: PAN-90806 Ophthalmic Suspension | Phase 1 Phase 2 |
Patients with newly diagnosed, active, pathologic CNV associated with neovascular AMD will be screened for inclusion into the study after providing written informed consent. Participants who are eligible for the study will be centrally randomized at Day 1 to one of three doses of PAN-90806 Eye Drops. Participants will be instructed to apply one drop of PAN-90806 to the ocular surface of the identified study eye once daily for twelve (12) weeks.
Participants will return for follow-up visits at Week 2, Week 4, Week 8, Week 12, 1 week after stopping PAN-90806 treatment and 1 month after stopping PAN-90806 treatment.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Masking will be maintained by using a coded drug supply. |
Primary Purpose: | Treatment |
Official 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) |
Actual Study Start Date : | April 26, 2018 |
Actual Primary Completion Date : | May 27, 2019 |
Actual Study Completion Date : | June 27, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: PAN-90806 Eye Drops, dose 1
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
|
Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Name: PAN-90806 Eye Drops |
Experimental: PAN-90806 Eye Drops, dose 2
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
|
Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Name: PAN-90806 Eye Drops |
Experimental: PAN-90806 Eye Drops, dose 3
PAN-90806 Ophthalmic Suspension taken once daily for 12 weeks
|
Drug: PAN-90806 Ophthalmic Suspension
PAN-90806 provided in single-use dropper bottles for topical ocular administration
Other Name: PAN-90806 Eye Drops |
- Number of participants with treatment-related adverse events [ Time Frame: up to 12 weeks ]
- Mean change from baseline in study eye ETDRS Visual Acuity [ Time Frame: through Week 12 ]
- Mean change from baseline in study eye retinal thickness [ Time Frame: through Week 12 ]
- Number of patients needing additional treatment with ranibizumab [ Time Frame: through Week 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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:
- Prior ocular or systemic treatment or surgery for neovascular AMD in the study eye
- Prior use within the last 3 months or a high possibility of requiring treatment with anti-VEGF therapy in the fellow eye during the study
- Significant retinal serous pigment epithelial detachment (PED), atrophy, or fibrosis/scar involving the fovea
- 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, and/or 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
- Women of child-bearing potential who are not using a highly effective form of birth control
- Known serious allergies or hypersensitivity to the fluorescein dye used in angiography or to the components of the PAN-90806 formulation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479372
United States, Colorado | |
Colorado Retina Associates | |
Golden, Colorado, United States, 80401 | |
United States, Maryland | |
Cumberland Valley Retina Consultants | |
Hagerstown, Maryland, United States, 21740 | |
United States, Nevada | |
Retinal Consultants of Nevada | |
Henderson, Nevada, United States, 89052 | |
Retinal Consultants of Nevada | |
Las Vegas, Nevada, United States, 89144 | |
United States, New Jersey | |
Retina Center of New Jersey | |
Bloomfield, New Jersey, United States, 07003 | |
Retina Center of New Jersey | |
Teaneck, New Jersey, United States, 07666 | |
United States, New Mexico | |
Vision Research Center | |
Albuquerque, New Mexico, United States, 87109 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
Czechia | |
Fakultní nemocnice Královské Vinohrady | |
Praha, Czechia, 100 34 | |
Axon Clinical | |
Praha, Czechia, 150 00 | |
Hungary | |
Semmelweis University | |
Budapest, Hungary, 1085 | |
University of Debrecen | |
Debrecen, Hungary, 4032 | |
Latvia | |
P. Stradina Clinical University hospital | |
Riga, Latvia, LV1002 | |
United Kingdom | |
Barnet Hospital | |
Barnet, Hertfordshire, United Kingdom, EN5 3DJ | |
New Cross Hospital | |
Wolverhampton, West Midlands, United Kingdom, WV10 0QP | |
Bradford Royal Infirmary | |
Bradford, United Kingdom, BD9 6RJ | |
Moorefields Eye Hospital | |
London, United Kingdom, EC1V 2PD | |
Manchester Royal Eye Hospital | |
Manchester, United Kingdom, M13 9WL |
Study Director: | Martin Wax, MD | PanOptica, Inc. |
Responsible Party: | PanOptica, Inc. |
ClinicalTrials.gov Identifier: | NCT03479372 |
Other Study ID Numbers: |
PAN-01-102 |
First Posted: | March 27, 2018 Key Record Dates |
Last Update Posted: | July 9, 2019 |
Last Verified: | July 2019 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
AMD wet AMD exudative AMD macular degeneration |
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases |
Eye Diseases Ophthalmic Solutions Pharmaceutical Solutions |