Rocklatan Retinal Perfusion OCT Study

NCT07174401 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: OHSU IRB0029104
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to learn more about how Rocklatan eye drops affects blood flow in the eye. The secondary purpose is to see if our study devices can detect changes in blood flow before and after instillation of Rocklatan.

Conditions

Glaucoma

Keywords

Glaucoma; Rocklatan

Outcome Measures

Primary Outcomes (1)

• Nerve Fiber Layer Plexus Capillary Density (NFLP CD)

  The primary outcome measure will be change in the overall peripapillary NFLP CD measured at 6 months and 11-12 month endpoint visits compared to baseline values.

  From enrollment to end of treatment at 11-12 months

Secondary Outcomes (1)

• Total Retinal Blood Flow (TRBF)

  From enrollment to end of treatment at 11-12 months

Study Arms (2)

Eye with Diagnosed Glaucoma

EXPERIMENTAL

Drug: Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.; Device: Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.

Control Eye

NO INTERVENTION

This is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug.

Interventions

Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. DEVICE

One OCT device is FDA-cleared while the other is still experimental. Both devices assess blood flow in different ways.

Eye with Diagnosed Glaucoma

Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. DRUG

The eye not selected as the study eye will be used for comparison so both eyes will be imaged with the study devices to assess blood flow changes.

Eye with Diagnosed Glaucoma

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with both eyes with open angle glaucoma.
• Abnormal VF (glaucomatous pattern with PSD abnormal at p\<0.05 or GHT outside normal limits) on most recent two clinic visits on chart review
• Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
• Overall average NFL thickness \> 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
• NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
• The difference in baseline NFLP-CD between the left and right eye should be less than 5% (% of area).
• IOP \>= 17 mm Hg on the most recent two clinic visits (chart review) after monotherapy with latanoprost in both eyes.

You may not qualify if:

• Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
• Age \< 21 years at baseline
• Eye disease that could affect VF, NFL thickness, or NFLP (e.g., visually significant cataract, AMD, diabetic retinopathy, and optic neuropathy) at any study visit
• OCT and OCTA scans not meeting quality criteria at baseline
• Inability to cooperate with study procedures
• Inability to commit to the study visits

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Alcon Research: collaborator

Study Sites (1)

Casey Eye Institute - Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Officials

• David Huang, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinmay Deshpande, MS Optom

CONTACT

503-494-9628; deshpanc@ohsu.edu

Denzil Romfh, OD

CONTACT

503-494-4351; romfhd@ohsu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The investigator will assign one eye to use the study drug, while the other eye (control) will remain on the clinically prescribed medication. The identity of the eye drop will be masked to both participants and study personnel who perform testing procedures or data analysis. The university research pharmacy will provide label masked bottles for each eye.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)