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Retinal Blood Flow Assessment for Glaucoma

Phase 4
Recruiting
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
2) Pre-perimetric glaucoma defined by optic nerve damage and absence of definite glaucomatous visual field defect
1) Early Glaucoma as per Hodapp-Anderson-Parrish Criteria with specific visual field defects
Must not have
Secondary glaucoma
History of prior ocular surgery other than uncomplicated cataract surgery or laser trabeculoplasty
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

This trial will help establish if changes in retinal blood flow could be an early marker for primary open angle glaucoma.

Who is the study for?
This trial is for adults over 18 with early or pre-perimetric glaucoma, and a control group without glaucoma. Participants must not have had ocular surgery (except cataract surgery/laser trabeculoplasty), no diabetes/hypertension/vascular disorders, no retinal diseases affecting the nerve layer, non-smokers for at least 6 months, and able to be off glaucoma meds for four weeks.
What is being tested?
The study tests how well blood flow in the retina adjusts itself in people with early-stage open-angle glaucoma using Indocyanine Green Angiography, Isocapnic Oxygen inhalation, and advanced imaging techniques like OCT and AO to potentially identify new biomarkers.
What are the potential side effects?
While specific side effects are not listed for these diagnostic interventions, they may include discomfort from bright lights during imaging procedures or temporary dizziness/breathlessness from inhaling isocapnic oxygen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have early-stage glaucoma without clear vision loss.
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I have early-stage glaucoma with specific vision field issues.
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I am over 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with secondary glaucoma.
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I have had eye surgery, but only for cataracts or glaucoma.
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I have eye conditions that affect pressure measurements.
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I have a condition that affects the thickness of my retina's nerve layer.
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I have diabetes, high blood pressure, or a blood vessel disease.
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I have a cataract that is moderately severe or worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Autoregulation of retinal blood flow

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Isocapnic OxygenExperimental Treatment3 Interventions
Investigators will evaluate retinal blood flow in response to oxygen supplementation.

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
381,024 Total Patients Enrolled
2 Trials studying Glaucoma
160 Patients Enrolled for Glaucoma

Media Library

Ocular Imaging with Optical Coherence Tomography (OCT) and Adaptive Optics (AO) Clinical Trial Eligibility Overview. Trial Name: NCT05344274 — Phase 4
Glaucoma Research Study Groups: Isocapnic Oxygen
Glaucoma Clinical Trial 2023: Ocular Imaging with Optical Coherence Tomography (OCT) and Adaptive Optics (AO) Highlights & Side Effects. Trial Name: NCT05344274 — Phase 4
Ocular Imaging with Optical Coherence Tomography (OCT) and Adaptive Optics (AO) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05344274 — Phase 4
~35 spots leftby Sep 2026
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