Proliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentPhase 2TOPO-RDNCT05523869
Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
A Phase 2 study testing Intravitreal topotecan and Pars plana vitrectomy with or without scleral buckle in people with Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment, run by Unity Health Toronto at 2 sites in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
- What is being tested?
- Intravitreal topotecan and Pars plana vitrectomy with or without scleral buckle
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- 23 Feb 2023to Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4Y 1H1
Peter Kertes, MD, 416-480-4244
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Rajeev Muni, (416) 867-7411
About this study
Official title: A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
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.
- Being tested
- Intravitreal topotecan, Pars plana vitrectomy with or without scleral buckle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal topotecanDrug
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.
Pars plana vitrectomy with or without scleral buckleProcedure or surgery
Standard three-port pars plana vitrectomy with or without scleral buckle.
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle | Experimental | Not described Receives: Drug: Intravitreal topotecan; Procedure: Pars plana vitrectomy with or without scleral buckle |
| Pars plana vitrectomy with or without scleral buckle | Active comparator | Not described Receives: Procedure: Pars plana vitrectomy with or without scleral buckle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent RRD secondary to PVR
Measured: 6 months or last follow-up
Secondary outcomes (5)
Best corrected visual acuity
Measured: 6 months or last follow-up
Proliferative vitreoretinopathy grade
Measured: 6 months or last follow-up
Retinal reattachment rate
Measured: 6 months or last follow-up
Complications
Measured: 6 months or last follow-up
Best corrected visual acuity change from baseline
Measured: 6 months or last follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2022
- Study start23 Feb 2023
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05523869
- Sponsor's protocol ID
- TOPO-RD
- Acronym
- TOPO-RD
- Status last verified
- Feb 2025
- First submitted
- 29 Aug 2022
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
- ClinicalTrials.gov ID
- NCT05523869
- Acronym / sponsor ID
- TOPO-RD / TOPO-RD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 31 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle | Experimental | Drug: Intravitreal topotecan, Procedure: Pars plana vitrectomy with or without scleral buckle |
| Pars plana vitrectomy with or without scleral buckle | Active comparator | Procedure: Pars plana vitrectomy with or without scleral buckle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal topotecanPatients 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. | Drug | Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle |
| Pars plana vitrectomy with or without scleral buckleStandard three-port pars plana vitrectomy with or without scleral buckle. | Procedure or surgery | Intravitreal topotecan with pars plana vitrectomy with or without scleral buckle, Pars plana vitrectomy with or without scleral buckle |
Primary outcome
Recurrent RRD secondary to PVR
Time frame: 6 months or last follow-up
5 secondary outcomes
Best corrected visual acuity
Time frame: 6 months or last follow-up
Proliferative vitreoretinopathy grade
Time frame: 6 months or last follow-up
Retinal reattachment rate
Time frame: 6 months or last follow-up
Complications
Time frame: 6 months or last follow-up
Best corrected visual acuity change from baseline
Time frame: 6 months or last follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravitreal topotecan and Pars plana vitrectomy with or without scleral buckle in people with Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment, run by Unity Health Toronto at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rajeev Muni, MD (416-867-7411, rajeev.muni@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent RRD secondary to PVR (time frame: 6 months or last follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2025.