Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy (TOPO-RD)
Primary Purpose
Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Intravitreal topotecan
Pars plana vitrectomy with or without scleral buckle
Sponsored by
About this trial
This is an interventional treatment trial for Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Eligibility Criteria
Inclusion criteria:
- Patients aged 18 years and older of any gender or race
- Patients who undergo pars plana vitrectomy for rhegmatogenous retinal detachment or in the context of open globe injury
- Patients with proliferative vitreoretinopathy grade C or D at initial presentation.
- Patients must be willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits
Exclusion criteria:
- History of tractional or exudative retinal detachment
- History of severe non-proliferative or proliferative diabetic retinopathy
- Patients with other planned ocular surgery (non-retinal surgery) following PPV
- Females of childbearing age
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
- St. Michael's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
Pars plana vitrectomy with or without scleral buckle
Arm Description
Outcomes
Primary Outcome Measures
Recurrent RRD secondary to PVR
Secondary Outcome Measures
Best corrected visual acuity
Proliferative vitreoretinopathy grade
Retinal reattachment rate
Complications
Best corrected visual acuity change from baseline
Full Information
NCT ID
NCT05523869
First Posted
August 29, 2022
Last Updated
February 27, 2023
Sponsor
Unity Health Toronto
1. Study Identification
Unique Protocol Identification Number
NCT05523869
Brief Title
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy
Acronym
TOPO-RD
Official Title
A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
February 2025 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Health Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intravitreal topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that we hypothesize may exhibit high efficacy for the treatment of proliferative vitreoretinopathy (PVR) in patients with rhegmatogenous retinal detachment (RRD). A high efficacy for intravitreal topotecan has been exhibited in cell cultures of PVR. At the same time, intravitreal topotecan has been routinely used in the treatment of vitreous seeds from retinoblastoma. At doses of 5-30 micrograms per injection, no adverse events have been reported with the use of intravitreal topotecan. Therefore, the current prospective matched phase II trial aims to investigate the efficacy and safety of intravitreal topotecan for severe PVR in patients with RRD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle
Arm Type
Experimental
Arm Title
Pars plana vitrectomy with or without scleral buckle
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Intravitreal topotecan
Intervention Description
Patients meeting all inclusion criteria and not meeting exclusion criteria will be assigned to receive pars plana vitrectomy with or without scleral buckle with intravitreal topotecan 8 µg/0.1mL, administered preoperatively within one week from surgery, intraoperatively during surgery, as well as postoperatively at 2 weeks, 4 weeks, 8 weeks, 12 weeks and 16 weeks, for a total of 7 injections.
Intervention Type
Procedure
Intervention Name(s)
Pars plana vitrectomy with or without scleral buckle
Intervention Description
Standard three-port pars plana vitrectomy with or without scleral buckle.
Primary Outcome Measure Information:
Title
Recurrent RRD secondary to PVR
Time Frame
6 months or last follow-up
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
6 months or last follow-up
Title
Proliferative vitreoretinopathy grade
Time Frame
6 months or last follow-up
Title
Retinal reattachment rate
Time Frame
6 months or last follow-up
Title
Complications
Time Frame
6 months or last follow-up
Title
Best corrected visual acuity change from baseline
Time Frame
6 months or last follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
To be enrolled, patients need to meet the following inclusion criteria:
patients aged 18 years and older
patients who undergo PPV and/or SB for recurrent RRD due to PVR
patients with RRD and PVR grade C or D
patients who have failed standard of care surgery for RRD in the same eye previously. In order to satisfy this inclusion criterion, patients need to have previously received at least one vitreoretinal surgery for RRD, including pneumatic retinopexy, pars plana vitrectomy and/or scleral buckle, and to have clinical documentation supporting re-detachment of the retina after one or more vitreoretinal surgeries for RRD in the same eye. This cohort of patients is expected to have an extremely guarded visual prognosis and visual potential.
patients who are voluntarily able and willing to participate Patients undergoing combined phacoemulsification and PPV and/or SB will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during PPV.
The following subject exclusion criteria will be considered:
patients with a history of tractional or exudative retinal detachment
patients with severe non-proliferative or proliferative diabetic retinopathy
patients with other planned ocular surgery following PPV
patients with primary RRD
female patients of childbearing age (i.e. less than 50 years old).
patients with pre-existing bone marrow suppression or cytopenias
patients with pre-existing interstitial lung disease (ILD) Any other medications or treatments, including rescue therapy, will be permitted before and/or during the trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rajeev Muni, MD
Phone
416-867-7411
Email
rajeev.muni@utoronto.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Marko Popovic, MD
Phone
416-867-7411
Email
marko.popovic@mail.utoronto.ca
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4Y 1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Kertes, MD
Phone
416-480-4244
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rajeev Muni
Phone
(416) 867-7411
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment With Proliferative Vitreoretinopathy
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