Clinical trial NCT05523869: Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
Official title: A Prospective Matched Cohort Study of Intravitreal Topotecan in the Repair of Rhegmatogenous Retinal Detachment with Proliferative Vitreoretinopathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: To be enrolled, patients need to meet the following inclusion criteria:

1. patients aged 18 years and older
2. patients who undergo PPV and/or SB for recurrent RRD due to PVR
3. patients with RRD and PVR grade C or D
4. 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.
5. 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:

1. patients with a history of tractional or exudative retinal detachment
2. patients with severe non-proliferative or proliferative diabetic retinopathy
3. patients with other planned ocular surgery following PPV
4. patients with primary RRD
5. female patients of childbearing age (i.e. less than 50 years old).
6. patients with pre-existing bone marrow suppression or cytopenias
7. 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.

Primary outcomes:
measure: Recurrent RRD secondary to PVR
timeFrame: 6 months or last follow-up
Secondary outcomes:
measure: Best corrected visual acuity
timeFrame: 6 months or last follow-up
measure: Proliferative vitreoretinopathy grade
timeFrame: 6 months or last follow-up
measure: Retinal reattachment rate
timeFrame: 6 months or last follow-up
measure: Complications
timeFrame: 6 months or last follow-up
measure: Best corrected visual acuity change from baseline
timeFrame: 6 months or last follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
References: