Rocklatan Retinal Perfusion OCT Study

Phase 4Not Yet RecruitingNCT07174401

Oregon Health and Science University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Glaucoma

Interventions

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.

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Casey Eye Institute - Oregon Health & Science University

Portland, Oregon, United States

Outcomes

Primary Outcomes

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.

Time frame: From enrollment to end of treatment at 11-12 months

Secondary Outcomes

Total Retinal Blood Flow (TRBF)

Secondary outcome measures will include change in the TRBF measured at 6 months or 11-12 month endpoint visits compared to baseline.

Time frame: From enrollment to end of treatment at 11-12 months

Central Contacts

Chinmay Deshpande, MS Optom

CONTACT

503-494-9628 deshpanc@ohsu.edu

Denzil Romfh, OD

CONTACT

503-494-4351 romfhd@ohsu.edu

Data from ClinicalTrials.gov

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