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New treatment option for Non-proliferative Diabetic Retinopathy (NPDR)
Official title Single-site Pilot Study Evaluating the Effect of QLS-111 Ophthalmic Solution on Posterior Perfusion and Vessel Dilation
ClinicalTrials.gov ID: NCT07354477
What this study is testing
What is QLS-111 Ophthalmic Solution (0.015%)?
QLS-111 Ophthalmic Solution (0.015%) is an investigational medicine, being studied as a potential treatment for non-proliferative diabetic retinopathy (npdr).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Pilot, single-site, prospective study of QLS-111 0.015 % in subjects with NPDR, OAG or NTG
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of mild to moderate OAG, mild to moderate NTG, or stable NPDR in at least one eye.
- Corrected visual acuity in each eye +1.0 logMAR or better by early treatment diabetic retinopathy study (ETDRS) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
You likely can't join if
- History of active ocular disease other than mild to moderate OAG, mild to moderate NTG, or stable NPDR.
- Patient is using more than 1 ocular hypotensive topical medication for intraocular pressure (IOP) control (prior MIGS and/or laser trabeculoplasty to...
- Use of TO β-blockers (i.e. timolol) within 3 months prior to Screening.
- Is noncompliant with current ocular anti-hypotensive medications and/or unwilling to be compliant throughout the study.
- Clinically significant severe retinal disease in either eye that will require treatment during the study (e.g., proliferative diabetic retinopathy...
- Anti-VEGF or TO steroid treatment within 3 months prior to Screening or expected treatment while participating in this study. Prior diabetic macular...
See the full eligibility criteria
- Diagnosis of mild to moderate OAG, mild to moderate NTG, or stable NPDR in at least one eye.
- Corrected visual acuity in each eye +1.0 logMAR or better by early treatment diabetic retinopathy study (ETDRS) in each eye (equivalent to 20/200).
- Able and willing to give signed informed consent and follow study instructions.
- History of active ocular disease other than mild to moderate OAG, mild to moderate NTG, or stable NPDR.
- Patient is using more than 1 ocular hypotensive topical medication for intraocular pressure (IOP) control (prior MIGS and/or laser trabeculoplasty to control IOP is allowed if done at least 3 months from Screening...
- Use of TO β-blockers (i.e. timolol) within 3 months prior to Screening.
- Is noncompliant with current ocular anti-hypotensive medications and/or unwilling to be compliant throughout the study.
- Clinically significant severe retinal disease in either eye that will require treatment during the study (e.g., proliferative diabetic retinopathy, exudative, or severe non-exudative macular degeneration). NOTE...
- Anti-VEGF or TO steroid treatment within 3 months prior to Screening or expected treatment while participating in this study. Prior diabetic macular edema (DME) history is allowed if adequately controlled with treatment...
- Previously diagnosed, clinically significant systemic or psychiatric disease (e.g., myasthenia gravis, hepatic, renal, endocrine, pulmonary, or cardiovascular disorders) which might compromise the study results or...
- Use of calcium channel blockers.
- Labile hypertension and/or hypotension that is inadequately controlled,
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.