Rocklatan Retinal Perfusion OCT Study

Oregon Health & Science University (OHSU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Glaucoma

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07174401

OHSU IRB0029104

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Eye with Diagnosed Glaucoma

Experimental group

Treatment:

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 group

Description:

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