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Intravitreal Topotecan for Proliferative Vitreoretinopathy

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Study AimThis study aims to evaluate the safety and effects of intravitreal Topotecan on preventing retinal detachment recurrence in patients with proliferative vitreoretinopathy.
What is being tested

Topotecan

Drug
Who is being recruted

Proliferative Vitreoretinopathy

+ Proliferative Vitreo-Retinopathy
+ Rhegmatogenous Retinal Detachment
Over 18 Years
+16 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2025

See protocol details

Summary

Principal SponsorMassachusetts Eye and Ear Infirmary
Study ContactLeo Kim, MD, PhD
Last updated: November 25, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2025Actual date on which the first participant was enrolled.

This study focuses on testing a new way to treat a condition called Proliferative Vitreoretinopathy (PVR), which can happen after a specific kind of retinal detachment known as rhegmatogenous retinal detachment (RRD). In PVR, unwanted cell growth occurs on and around the retina, which can lead to surgical failures when trying to fix the retinal detachment. Current treatments for PVR, like corticosteroids and 5-fluorouracil, do not work consistently well, so there is no standard treatment. The study is exploring the use of a drug called Topotecan, which has shown potential in treating similar eye conditions, to see if it can effectively and safely manage PVR. Participants in the study will receive Topotecan directly into the eye through an injection, a method known as intravitreal injection. This approach has been previously used for other eye conditions without causing major side effects. Researchers will carefully monitor the participants to evaluate the drug's effectiveness in reducing the unwanted cell growth associated with PVR and to ensure it does not cause any harm. The study aims to gather data on both the safety and potential benefits of using Topotecan to treat PVR, which could help in developing a more reliable treatment option for those affected by this condition.

Official TitleThe Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy 
Principal SponsorMassachusetts Eye and Ear Infirmary
Study ContactLeo Kim, MD, PhD
Last updated: November 25, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Proliferative Vitreoretinopathy
Proliferative Vitreo-Retinopathy
Rhegmatogenous Retinal Detachment
Criteria
3 inclusion criteria required to participate
Patients undergoing vitrectomy or vitrectomy with scleral buckle as part of standard care.
Patients presenting with retinal detachment due with PVR (grade C or higher) or retinal detachment associated with open globe trauma
Patients > 18 years old
13 exclusion criteria prevent from participating
Patients with other planned ocular surgery following PPV
Active or chronic or recurrent uncontrolled ocular or systemic disease
Active or history of chronic or recurrent inflammatory eye disease
Patient with silicone oil instilled in the operative eye at time of presentation

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
These are the patients who will be receiving intravitreally 20 micrograms of topotecan in a 1cc syringe during surgery, at the post-operative day 7 and at the post-operative day 28.
Group II
No Intervention
These patients will not be receiving any intervention.
Study Objectives
Primary Objectives

Investigators will be evaluating whether participant develop a recurrent retinal detachment throughout their follow up after their initial surgery.
Secondary Objectives

Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up

Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the grade of the PVR changes over time. PVR grade goes from grade A to grade C-Anterior to equator/ C-Posterior to equator (grade C being worse than grade A)

Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the retinal reattaches (whether completely or partially) after surgery

Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up

Any adverse event will be noted during surgery, and at each follow up visit for each participant if applicable.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 
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