OCRIPLASMIN FOR VITREOMACULAR TRACTION IN CLINICAL PRACTICE: The INJECT Study.

Details

Serval ID
serval:BIB_C2BF05CB0CB1
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
OCRIPLASMIN FOR VITREOMACULAR TRACTION IN CLINICAL PRACTICE: The INJECT Study.
Journal
Retina
Author(s)
Steel DHW, Patton N., Stappler T., Karia N., Hoerauf H., Patel N., Wachtlin J., Raber T., Kozma-Wiebe P.
Working group(s)
INJECT study investigators
ISSN
1539-2864 (Electronic)
ISSN-L
0275-004X
Publication state
Published
Issued date
01/02/2021
Peer-reviewed
Oui
Volume
41
Number
2
Pages
266-276
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Observational Study
Publication Status: ppublish
Abstract
Randomized clinical trials have demonstrated the safety and efficacy of ocriplasmin in patients with vitreomacular traction (VMT), including those with macular hole (MH). The INJECT study prospectively evaluated ocriplasmin in the setting of clinical practice.
INJECT was a Phase 4, multicenter, prospective observational study. Patients were followed up for 12 months. Assessments included nonsurgical VMT resolution, nonsurgical MH closure, best-corrected visual acuity, occurrence of vitrectomy, and adverse events.
The efficacy population (N = 395) received an ocriplasmin injection and had optical coherence tomography-confirmed VMT at baseline. At Day 28, the rate of nonsurgical VMT resolution was 40.7% in the overall group, and the rate of nonsurgical MH closure was 36.0% in the VMT with MH group. At Month 12, the rate of ≥2-line best-corrected visual acuity gain (irrespective of vitrectomy) was 36.8% in the overall group and 59.6% in the VMT with MH group. The percentage of patients who underwent vitrectomy in the study eye was 29.1% in the overall group and 55.6% in the VMT with MH group. Photopsia (9.8%) and vitreous floaters (6.8%) were the most frequent adverse events.
The INJECT study showed that ocriplasmin is effective in a clinical setting in patients with VMT, with or without MH. No new safety signals were identified from this large and surgeon-selected patient group, although the significant limitations of the study design without an image reading center and scheduled study visit timings should be noted.
Keywords
Aged, Aged, 80 and over, Female, Fibrinolysin/administration & dosage, Follow-Up Studies, Humans, Intravitreal Injections, Male, Middle Aged, Peptide Fragments/administration & dosage, Prospective Studies, Retinal Perforations/diagnosis, Retinal Perforations/therapy, Tomography, Optical Coherence/methods, Treatment Outcome, Vitrectomy/methods, Vitreous Body/pathology, Vitreous Detachment/diagnosis, Vitreous Detachment/therapy
Pubmed
Web of science
Open Access
Yes
Create date
10/06/2020 20:58
Last modification date
09/12/2023 8:04
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