Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)

Center for Sight Las Vegas

Status and phase: Not yet enrolling; Phase 4

Conditions: Primary Open Angle Glaucoma

Treatments: Drug: Rocklatan (netarsudil 0.02% and latanoprost 0.005%); Drug: Systane

Study type: Interventional

Funder types: Other

Identifiers

NCT07048886

96015755 (Other Grant/Funding Number)

CFS-RAPRAM-101

Details and patient eligibility

About

The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.

Full description

The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.

Enrollment: 68 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 40 years and older
• Subjects who have mild to moderate Open Angle Glaucoma (OAG)
• Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation > 3 months prior to screening and within the last 2 years
• Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)
• Unmedicated or washed out IOP range between 16-26 mmHg

Exclusion criteria

• History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation
• Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery
• Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome
• Severe Open Angle Glaucoma
• Narrow angles, other angle abnormalities or angle closure glaucoma
• Allergy or intolerance to Rocklatan
• History of corneal edema, or corneal disease or dystrophy
• Current or history of intra-ocular infection or inflammation
• History of retinal diseases that could affect diagnostic testing
• Anticipated use of intra-ocular or topical steroids not associated with the study protocol
• Pregnant, breastfeeding or planning to become pregnant during the study
• Any condition in the opinion in the investigator that would potentially confound the results of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 2 patient groups, including a placebo group

Placebo Comparator Systane Artificial Tears

Placebo Comparator group

Description:

Comparator arm is Systane artificial tears

Treatment:

Drug: Systane

FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%)

Active Comparator group

Description:

FDA approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%) is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Treatment:

Drug: Rocklatan (netarsudil 0.02% and latanoprost 0.005%)