Rocklatan Retinal Perfusion OCT Study

ConditionGlaucoma

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age21+

SponsorOregon Health and Science University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Eye with Diagnosed GlaucomaExperimental treatment 2 interventions

Group B: Control EyeNo intervention 0 interventions

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oregon Health and Science University

Lead sponsor

Alcon Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: