Trials / Terminated
TerminatedNCT05302609
Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
Phase II Study: Evaluation of SclerFIX Graft in Scleral Thinning After Exeresis of Tumors of the Ocular Surface
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- TBF Genie Tissulaire · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this open, multicenter phase II trial is to confirm the tolerance and evaluate the efficacy of the SclerFIX product, an allograft of umbilical cord lining membrane, in reinforcement of scleral thinning in patients who underwent eye tumor exeresis.
Detailed description
As scleral graft is forbidden in France, it cannot be used to reinforce the sclera. This study investigational product, SclerFIX, was developed to substitute scleral grafts.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SclerFIX | Chemically-treated, viro-inactivated, freeze-dried and irradiated umbilical cord lining membrane allograft used as substitute for scleral graft in reinforcement of scleral thinning. |
Timeline
- Start date
- 2022-07-04
- Primary completion
- 2024-02-21
- Completion
- 2024-02-21
- First posted
- 2022-03-31
- Last updated
- 2024-11-14
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05302609. Inclusion in this directory is not an endorsement.