Retinal Detachment RhegmatogenousPhase 2TOPO-PTNCT06818721
Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment
A Phase 2 study testing Intravitreal topotecan and Retinal detachment surgery in people with Retinal Detachment Rhegmatogenous and Proliferative Vitreoretinopathy, run by Unity Health Toronto at 2 sites in Canada.
Trial summary
Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Detachment Rhegmatogenous, Proliferative Vitreoretinopathy
- What is being tested?
- Intravitreal topotecan and Retinal detachment surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 394 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2025to Apr 2027
- 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
Who may be able to join
- Patients aged 18 years and older
- Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
- Patients who are voluntarily able and willing to participate
- Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.
Who cannot join
- Patients with a history of exudative retinal detachment
- Patients with severe non-proliferative or proliferative diabetic retinopathy
- Patients with other planned ocular surgery following pars plana vitrectomy
- Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
- Patients with pre-existing bone marrow suppression or cytopenias
- Patients with pre-existing interstitial lung disease
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
St. Michael's Hospital
Toronto, Ontario
Rajeev H Muni, MD MSc FRCSC, 416-867-7411, rajeev.muni@utoronto.ca
Rajeev H Muni, MD MSc FRCSC
Sunnybrook Health Sciences Centre
Toronto, Ontario
Peter J Kertes, MD CM FRCSC, 416-480-4244, peter.kertes@sunnybrook.ca
Peter J Kertes, MD CM FRCSC
About this study
Official title: Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study
Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.
Read the detailed description
Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.
- Being tested
- Intravitreal topotecan, Retinal detachment surgery
- Keywords
- topotecan, proliferative vitreoretinopathy, rhegmatogenous retinal detachment
- Medical subject headings
- Vitreoretinopathy, Proliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal topotecanDrug
Also called Topotecan
Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections.
Retinal detachment surgeryProcedure or surgery
Also called Pars plana vitrectomy, Pneumatic retinopexy, Scleral buckling
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal topotecan with retinal detachment surgery | Experimental | Intravitreal topotecan 8 µg/0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively. Receives: Drug: Intravitreal topotecan; Procedure: Retinal detachment surgery |
| Retinal detachment surgery | Active comparator | Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan. Receives: Procedure: Retinal detachment surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
Measured: 6 months or last follow-up
Secondary outcomes (6)
Grade of proliferative vitreoretinopathy
Measured: 6 months or last follow-up
Rate of primary retinal reattachment
Measured: 6 months or last follow-up
Rate of final retinal reattachment
Measured: 6 months or last follow-up
Best-corrected visual acuity
Measured: 6 months or last follow-up
Change in best-corrected visual acuity from baseline
Measured: 6 months or last follow-up
Rate of complications
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 posted10 Feb 2025
- Study startMar 2025 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal Detachment RhegmatogenousStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 394 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
- NCT06818721
- Sponsor's protocol ID
- TOPO-PT
- Acronym
- TOPO-PT
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2025
- Last updated
- 6 Mar 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study
- ClinicalTrials.gov ID
- NCT06818721
- Acronym / sponsor ID
- TOPO-PT / TOPO-PT
- Keywords
- topotecan, proliferative vitreoretinopathy, rhegmatogenous retinal detachment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 394 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Feb 2025 (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 exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.
Detailed description
Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravitreal topotecan with retinal detachment surgery | Experimental | Drug: Intravitreal topotecan, Procedure: Retinal detachment surgeryIntravitreal topotecan 8 µg/0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively. |
| Retinal detachment surgery | Active comparator | Procedure: Retinal detachment surgeryHistorical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years and older
- Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment
- Patients who are voluntarily able and willing to participate
- Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.
Key exclusion criteria (6 listed)
- Patients with a history of exudative retinal detachment
- Patients with severe non-proliferative or proliferative diabetic retinopathy
- Patients with other planned ocular surgery following pars plana vitrectomy
- Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study
- Patients with pre-existing bone marrow suppression or cytopenias
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 topotecanAlso: TopotecanPatients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections. | Drug | Intravitreal topotecan with retinal detachment surgery |
| Retinal detachment surgeryAlso: Pars plana vitrectomy, Pneumatic retinopexy, Scleral bucklingStandard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling). | Procedure or surgery | Intravitreal topotecan with retinal detachment surgery, Retinal detachment surgery |
Primary outcome
Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy
Time frame: 6 months or last follow-up
6 secondary outcomes
Grade of proliferative vitreoretinopathy
Time frame: 6 months or last follow-up
Rate of primary retinal reattachment
Time frame: 6 months or last follow-up
Rate of final retinal reattachment
Time frame: 6 months or last follow-up
Best-corrected visual acuity
Time frame: 6 months or last follow-up
Change in best-corrected visual acuity from baseline
Time frame: 6 months or last follow-up
Rate of complications
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 6 Mar 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 Retinal detachment surgery in people with Retinal Detachment Rhegmatogenous and Proliferative Vitreoretinopathy, 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?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: opening soon, as of the sponsor's last update on 6 Mar 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 H Muni, MD MSc FRCSC (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?
Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy (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 6 Mar 2025.