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Monoclonal Antibodies

Primary Prophylactic Vasoconstricting Eye Drops for Ovarian Cancer

Phase 2

Waitlist Available

Research Sponsored by ImmunoGen, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 and day 8 of cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Awards & highlights

Study Summary

This trial aims to study how often and how severe eye-related side effects are in patients with recurrent ovarian cancer who are treated with mirvetuximab soravtansine. The study will also

Who is the study for?

This trial is for individuals with recurrent ovarian cancer showing high folate receptor-alpha expression. It's open to those who've had either platinum-sensitive or platinum-resistant types of the disease.Check my eligibility

What is being tested?

The study tests if eye drops like Prednisolone acetate and Brimonidine tartrate can prevent or reduce eye problems caused by Mirvetuximab Soravtansine, a drug used in treating this cancer.See study design

What are the potential side effects?

Possible side effects include ocular issues such as blurred vision, dry eyes, irritation, and potentially toxic optic neuropathy related to Mirvetuximab Soravtansine treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 and day 8 of cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 and day 8 of cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 8 of cycles 1 through 4 up to 18 weeks or at the 30-day follow-up visit, whichever is earlier (cycle length = 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With MIRV-related Corneal AEs (≥ Grade 2) in Asymptomatic Participants

Secondary outcome measures

Area Under the Curve (AUC) of MIRV

Maximum Serum Concentration (Cmax) of MIRV

National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Composite Score

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Primary Prophylactic Vasoconstricting Eye DropsExperimental Treatment3 Interventions

Primary prophylactic brimonidine tartrate ophthalmic solution eye drops 3 times daily (TID) throughout the cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow brimonidine dosing, when given, by approximately 15 minutes); MIRV 6 mg/kg AIBW Q3W. Each cycle length = 21 days.

Group II: Primary Prophylactic Steroid Eye DropsExperimental Treatment3 Interventions

Prednisolone acetate ophthalmic suspension 1% 6 times daily on Days -1 to 4 and 4 times daily (QID) on Days 5 to 8 of each cycle; Lubricating eye drops QID throughout the entire cycle (doses should follow steroid dosing, when given, by approximately 15 minutes); MIRV 6 milligrams (mg)/kilogram (kg) adjusted ideal body weight (AIBW) every 3 weeks (Q3W). Each cycle length = 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mirvetuximab Soravtansine

2017

Completed Phase 3

~250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ImmunoGen, Inc.Lead Sponsor

32 Previous Clinical Trials

3,731 Total Patients Enrolled

5 Trials studying Ovarian Cancer

1,013 Patients Enrolled for Ovarian Cancer

Sheri Spunt, MDStudy DirectorImmunoGen, Inc.

1 Previous Clinical Trials

588 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings for patients to participate in this medical study?

"The clinical trial, as per information from clinicaltrials.gov, is not presently seeking participants. Originally shared on June 30th, 2024 and last modified on April 10th of the same year. Despite this trial being inactive in recruitment at present, there are a substantial number of 1485 other trials actively enrolling patients currently."

Answered by AI

Do multiple sites in Canada conduct this clinical trial?

"At present, this research study is actively enlisting participants at 25 distinct sites. Noteworthy cities hosting these sites include Durham, Dallas, and Clayton among an additional 22 locations. Opting for a site in close proximity could reduce the need to travel extensively during your involvement."

Answered by AI

Has the FDA granted approval for Primary Prophylactic Steroid Eye Drops?

"In this Phase 2 trial, the safety rating for Primary Prophylactic Steroid Eye Drops has been assessed as a 2 by our team at Power. This indicates that while some safety data exists, no evidence of efficacy has been observed yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression

2024. "A Study of Ocular Toxicity Evaluation and Mitigation During Treatment With Mirvetuximab Soravtansine in Participants With Recurrent Ovarian Cancer With High Folate Receptor-Alpha Expression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06365853.

All > Toxicity > Recurrent Ovarian Cancer