Discovery and Preclinical Development of Netarsudil, a Novel Ocular Hypotensive Agent for the Treatment of Glaucoma.
Cheng-Wen Lin, Bryan Sherman, Lori A Moore...
https://pubmed.ncbi.nlm.nih.gov/28609185Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
ID06033703
Topical Netarsudil for Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment Due to Rhegmatogenous Detachments or Proliferative Vitreoretinopathy or Open-Globe Injury
Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-10-28
48
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of topical netarsudil to prevent the formation of tractional membranes in patients with retinal detachment, focusing on its pharmacokinetics and safety during the pre- and post-operative periods. This study also aims to explore early signs of how well netarsudil may work to prevent these membranes after surgery. The trial involves two patient groups: those with primary rhegmatogenous retinal detachments and those with proliferative vitreoretinopathy or retinal detachment related to open globe trauma. This open-label, randomized trial administers netarsudil ophthalmic solution 0.02% once daily from diagnosis through 16 weeks after surgery. Patients are divided into four groups based on lens status (phakic or pseudophakic) and type of retinal detachment. All participants receive the same once-daily topical netarsudil treatment while undergoing vitrectomy or vitrectomy with scleral buckle surgery. Participants will be closely monitored with regular assessments including netarsudil concentration in the vitreous, serious and other adverse events, number of surgeries needed within three months, final retinal attachment status, visual acuity, and imaging of the macula using spectral domain optical coherence tomography. These evaluations occur at multiple points from surgery through 168 days post-operation, with the total study participation lasting about a year. The safety profile and pharmacokinetics of netarsudil, along with early signs of effectiveness, are key outcomes of this research.
CONDITIONS
Brief Title
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Patients older than 18 years
- Patients presenting for primary rhegmatogenous retinal detachment repair within 28 days of symptom onset
- Patients undergoing vitrectomy or vitrectomy with scleral buckle
- Patients presenting with retinal detachment due to proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma
- Patients able to give consent and follow-up
You will not qualify if you...
- Patient unable to give consent
- Patient unable to follow-up
- Prior history of retinal detachment incisional surgery in presenting eye
- Prior history of open globe injury to presenting eye
- Prior history of glaucoma surgery to presenting eye (e.g., trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery)
- Prior history of corneal disease or corneal edema
- Patient already on topical netarsudil in presenting eye
- Patient without natural lens or intraocular lens implant (aphakic patients)
- Intraocular pressure below 8 mm Hg in operative eye
- Active, chronic, or recurrent uncontrolled ocular or systemic disease
- Active or history of chronic or recurrent inflammatory eye disease
- Diagnosis of proliferative diabetic retinopathy (primary cohort) or severe nonproliferative/proliferative diabetic retinopathy or vasoproliferative disease (proliferative vitreoretinopathy cohort)
- Signs of ocular infection at presentation in either eye
- Known or suspected sensitivity or allergy to any medications used in operation or postoperatively
- Inability to use or apply topical eye drops
- No light perception vision in operative eye (proliferative vitreoretinopathy cohort)
- Failure to achieve intraoperative reattachment (proliferative vitreoretinopathy cohort)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - From diagnosis to 16 weeks post-operatively
Participants apply topical Netarsudil once daily from the time of diagnosis of retinal detachment through 16 weeks after surgery.
5 visits after surgery (Day 1, 7, 28, 84, and 168)
Trial Site Locations
Total: 1 location
1
Mass Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
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Research Team
L
Leo Kim, MD, PhD
C
Center for Clinical Research Operations (CCRO)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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Published Research Related To This Trial
Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients With Open-angle Glaucoma or Ocular Hypertension.
Inder P Singh, Robert D Fechtner, Jonathan S Myers...
https://pubmed.ncbi.nlm.nih.gov/32826769Pilot Study of Corneal Clearance With the Use of a Rho-Kinase Inhibitor After Descemetorhexis Without Endothelial Keratoplasty for Fuchs Endothelial Corneal Dystrophy.
Emma Davies, Ula Jurkunas, Roberto Pineda
https://pubmed.ncbi.nlm.nih.gov/33758139Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2).
Malik Y Kahook, Janet B Serle, Francis S Mah...
https://pubmed.ncbi.nlm.nih.gov/30653957Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2).
Janet B Serle, L Jay Katz, Eugene McLaurin...
https://pubmed.ncbi.nlm.nih.gov/29199013Reticular Epithelial Edema in Edematous Corneas Treated with Netarsudil.
Mark M Fernandez
https://pubmed.ncbi.nlm.nih.gov/30318038Reticular Bullous Epithelial Edema in Corneas Treated with Netarsudil: A Case Series.
C Ellis Wisely, Katy C Liu, Divakar Gupta...
https://pubmed.ncbi.nlm.nih.gov/32289295Transient Reticular Cystic Corneal Epithelial Edema With Topical Netarsudil: A Case Series and Review.
Stephen A LoBue, Giannis A Moustafa, Anderson Vu...
https://pubmed.ncbi.nlm.nih.gov/33369939