Rocklatan Retinal Perfusion OCT Study

Not Applicable

Not yet recruiting

• Conditions: Glaucoma
• Interventions: 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.

• Registration Number: NCT07174401
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-16
• Last Update Posted: 2025-09-16
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients with both eyes with open angle glaucoma.
2. 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
3. Glaucomatous disc abnormality on chart review and confirmed on baseline disc photograph
4. Overall average NFL thickness > 55 μm measured by Heidelberg Spectralis OCT -Glaucoma Module Premium Edition (chart review), consistent with early glaucoma
5. NFLP-CD deficit (below 5 percentile of normal) in any of the 8 sectors on the initial baseline visit
6. The difference in baseline NFLP-CD between the left and right eye should be less than 5% (% of area).
7. IOP >= 17 mm Hg on the most recent two clinic visits (chart review) after monotherapy with latanoprost in both eyes.

Exclusion Criteria

1. Best corrected visual acuity worse than 20/30 on chart review of most recent clinic visit
2. Age < 21 years at baseline
3. 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
4. OCT and OCTA scans not meeting quality criteria at baseline
5. Inability to cooperate with study procedures
6. Inability to commit to the study visits

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eye with Diagnosed Glaucoma	Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months.	-
Eye with Diagnosed Glaucoma	Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.	-

Primary Outcome Measures

Name	Time	Method
Nerve Fiber Layer Plexus Capillary Density (NFLP CD)	From enrollment to end of treatment at 11-12 months	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.

Secondary Outcome Measures

Name	Time	Method
Total Retinal Blood Flow (TRBF)	From enrollment to end of treatment at 11-12 months	Secondary outcome measures will include change in the TRBF measured at 6 months or 11-12 month endpoint visits compared to baseline.

Trial Locations

Locations (1)

Casey Eye Institute - Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States