Rocklatan Retinal Perfusion OCT Study

NCT07174401 — Phase 4, Not yet recruiting, 30 participants, Oregon Health and Science University

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Rocklatan Trial With Optical Coherence Tomography Study of Retinal Perfusion

RegistryNCT07174401
StatusNot yet recruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: double, treatment
Enrollment30 (Estimated)
SponsorOregon Health and Science University (Other); collaborators: Alcon Research
ConditionsGlaucoma
InterventionsRocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months., Two optical coherence tomography (OCT) devices will be used to assess blood flow changes. (Drug, device)
Datesstart 2026-01-01 (estimated), primary completion 2026-12-01 (estimated), completion 2027-10-01 (estimated), first posted 2025-09-16, last updated 2025-12-24
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Glaucoma All trials of Rocklatan eye drops will be instilled nightly in one eye diagnosed with glaucoma for up to 12 months. All trials of Two optical coherence tomography (OCT) devices will be used to assess blood flow changes.

-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.

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Eye with Diagnosed GlaucomaExperimentalDrug: 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 EyeNo interventionThis is also an eye with glaucoma, but the control eye will use clinically prescribed medication instead of the study drug.
  • 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

Sex: All, ages: 21 Years to any

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)

FacilityCityCountryStatus
Casey Eye Institute - Oregon Health & Science UniversityPortland, OregonUnited States

+Investigators