Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion
Purpose: To evaluate the efficacy and the safety of the enzymatic vitreolysis with a single intravitreal injection of ocriplasmin 125 μg across a group of patients with symptomatic vitreomacular adhesion (sVMA) during 6 months follow up. Design: A randomized, placebo-controlled, double-masked, 6-mo...
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Eleven Senses
2016-03-01
|
| Series: | Senses and Sciences |
| Subjects: | |
| Online Access: | http://www.sensesandsciences.com/pacella-2016 |
| _version_ | 1811285316023091200 |
|---|---|
| author | Fernanda Pacella Athanasios Nikolakopoulos Roberto Secondi Anna Santa Guzzo Antonella Mollicone Elena Pacella Kostantinos Nikolakopoulos |
| author_facet | Fernanda Pacella Athanasios Nikolakopoulos Roberto Secondi Anna Santa Guzzo Antonella Mollicone Elena Pacella Kostantinos Nikolakopoulos |
| author_sort | Fernanda Pacella |
| collection | DOAJ |
| description | Purpose: To evaluate the efficacy and the safety of the enzymatic vitreolysis with a single intravitreal injection of ocriplasmin 125 μg across a group of patients with symptomatic vitreomacular adhesion (sVMA) during 6 months follow up.
Design: A randomized, placebo-controlled, double-masked, 6-month follow up study.
Participants: A total of 28 patients (12 M / 16F) (19 receiving ocriplasmin; 9 receiving placebo), mean aged 71 years old, diagnosed with sVMA, VMT, FTMH e ERM by optical coherence tomography.
Methods: A single intravitreal injection of ocriplasmin 125 μg or placebo. Primary endpoint was sVMA resolution or FTMH closure. Secondary endpoint included the integrity of the external membrane and the inner and outer segments of the photoreceptor interface using OCT. The evaluation was carried out at baseline and during 6 months after intravitreal injection of ocriplasmin or placebo.
Results: After a 6 months follow-up period, the rate of VMA resolution was 42.1% in the Ocriplasmin group vs the 22% in the placebo group. FTMH closure rate was 50% in the Ocriplasmin group vs 0% in the placebo group. The best results were optained within 28 days from the treatment. No case of uveitis, endophthalmitis, retinal tears, retinal detachment or bleeding during follow-up were reported. One patient reported floaters and transitional photopsias.
Conclusions: The study confirmed the efficacy and safety of Ocriplasmin injection for patients with VMT, including when associated with full-thickness macular holes during six months follow up. Long term studies are certainly needed to confirm these results. |
| first_indexed | 2024-04-13T02:42:10Z |
| format | Article |
| id | doaj.art-860dfa5685b749dab0ca4db780119623 |
| institution | Directory Open Access Journal |
| issn | 2284-2489 |
| language | English |
| last_indexed | 2024-04-13T02:42:10Z |
| publishDate | 2016-03-01 |
| publisher | Eleven Senses |
| record_format | Article |
| series | Senses and Sciences |
| spelling | doaj.art-860dfa5685b749dab0ca4db7801196232022-12-22T03:06:10ZengEleven SensesSenses and Sciences2284-24892016-03-013117017510.14616/sands-2016-1-170175Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesionFernanda Pacella0Athanasios Nikolakopoulos1Roberto Secondi2Anna Santa Guzzo3Antonella Mollicone4Elena Pacella5Kostantinos Nikolakopoulos6Department of Sense Organs, Faculty of Medicine and Dentistry Sapienza University of Rome, Italy2 Department Papanikolaou Hospital, Thessaloniki, GreeceDepartment of Sense Organs, Faculty of Medicine and Dentistry Sapienza University of Rome, ItalyRisk Manager Academic Hospital Policlinico Umberto I Sapienza University of Rome,ItalyDepartment of Sense Organs, Faculty of Medicine and Dentistry Sapienza University of Rome, ItalyDepartment of Sense Organs, Faculty of Medicine and Dentistry Sapienza University of Rome, ItalyDepartment of Sense Organs, Faculty of Medicine and Dentistry Sapienza University of Rome, ItalyPurpose: To evaluate the efficacy and the safety of the enzymatic vitreolysis with a single intravitreal injection of ocriplasmin 125 μg across a group of patients with symptomatic vitreomacular adhesion (sVMA) during 6 months follow up. Design: A randomized, placebo-controlled, double-masked, 6-month follow up study. Participants: A total of 28 patients (12 M / 16F) (19 receiving ocriplasmin; 9 receiving placebo), mean aged 71 years old, diagnosed with sVMA, VMT, FTMH e ERM by optical coherence tomography. Methods: A single intravitreal injection of ocriplasmin 125 μg or placebo. Primary endpoint was sVMA resolution or FTMH closure. Secondary endpoint included the integrity of the external membrane and the inner and outer segments of the photoreceptor interface using OCT. The evaluation was carried out at baseline and during 6 months after intravitreal injection of ocriplasmin or placebo. Results: After a 6 months follow-up period, the rate of VMA resolution was 42.1% in the Ocriplasmin group vs the 22% in the placebo group. FTMH closure rate was 50% in the Ocriplasmin group vs 0% in the placebo group. The best results were optained within 28 days from the treatment. No case of uveitis, endophthalmitis, retinal tears, retinal detachment or bleeding during follow-up were reported. One patient reported floaters and transitional photopsias. Conclusions: The study confirmed the efficacy and safety of Ocriplasmin injection for patients with VMT, including when associated with full-thickness macular holes during six months follow up. Long term studies are certainly needed to confirm these results.http://www.sensesandsciences.com/pacella-2016vitreomacular adhesionocriplasminintravitreal injectionenzymatic vitreolysis |
| spellingShingle | Fernanda Pacella Athanasios Nikolakopoulos Roberto Secondi Anna Santa Guzzo Antonella Mollicone Elena Pacella Kostantinos Nikolakopoulos Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion Senses and Sciences vitreomacular adhesion ocriplasmin intravitreal injection enzymatic vitreolysis |
| title | Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion |
| title_full | Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion |
| title_fullStr | Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion |
| title_full_unstemmed | Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion |
| title_short | Six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion |
| title_sort | six months follow up of a single intravitreal injection of ocriplasmin for symptomatic vitreomacular adhesion |
| topic | vitreomacular adhesion ocriplasmin intravitreal injection enzymatic vitreolysis |
| url | http://www.sensesandsciences.com/pacella-2016 |
| work_keys_str_mv | AT fernandapacella sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion AT athanasiosnikolakopoulos sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion AT robertosecondi sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion AT annasantaguzzo sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion AT antonellamollicone sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion AT elenapacella sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion AT kostantinosnikolakopoulos sixmonthsfollowupofasingleintravitrealinjectionofocriplasminforsymptomaticvitreomacularadhesion |