A Phase 2 interventional study of SclerFIX in Scleral Thinning, sponsored by TBF Genie Tissulaire. Terminated at 2 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-14.
Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment
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.
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.
TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patch of umbilical cord lining membrane sutured on top of the scleral defect.
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.
Rate of tectonic success of the graft at 3 months
The graft will be considered successful at 3 months if the curvature of the eye is respected without thinning, i.e., in the absence of edema, ulceration and loss of substance (thickness of the grafted area/thickness of the adjacent surface \> 80%). The scleral thickness will be determined from images obtained by optical coherence tomography (OCT).
Time frame: 3 months
Absence of inflammatory reactions and good local tolerance of the implant
Composite score evaluating the presence of local reactions (edema, redness, vascularization, discharge) and of ulceration, pain and foreign body sensation (0: excellent local tolerance, 46: worst possible local tolerance)
Time frame: 15 days, 1 month, 3 months
Evaluation of the visual acuity
Scoring of blurred and poor vision (0: never, 4: all the time)
Time frame: 15 days, 1 month, 3 months
Evaluation of the eye pressure
Measure of eye pressure using a tonometer
Time frame: 15 days, 1 month, 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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TBF Genie Tissulaire