This case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab (Lucentis®) in the treatment of macular edema due to central retinal vein occlusion. MedDRA version: 12.1 Level: LLT Classification code 10007972 Term: Central retinal vein occlusion MedDRA version: 12.1 Level: LLT Classification code 10054467 Term: Macular edema
Conditions
Interventions
Trade Name: Lucentis 10 mg/ml Injektionslösung
Product Code: not applicable
Pharmaceutical Form: Solution for injection
INN or Proposed INN: RANIBIZUMAB
CAS Number: 347396-82-1
Concentration unit: mg/
Sponsors
Medizinische Universität Graz, Universitäts-Augenklinik
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who at baseline 1. have a best corrected visual acuity (BCVA) in the study eye between 20/40 to 20/400 (EDTRS charts, visual acuity measured at 4 meters). 2. have clinical, angiographical and optical coherence tomography (OCT) evidence (central retinal thickness >250µm) of macular edema due to CRVO. 3. are willing and able to provide written informed consent. 4. are willing to return for the scheduled visits for a 12 month period. 5. Only one eye will be assessed in the study. If both eyes are eligible, the one with worse visual acuity will be selected for treatment and study unless, based on medical reasons, the investigators deem the other eye the more appropriate candidate for treatment and study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who at baseline 1. are younger than 19 years of age. 2. are mentally disabled. 3. are participating in another clinical study. 4 show a decrease in visual acuity due to causes other than CRVO e.g. history of exudative age-related macular degeneration, diabetic macular edema, choroidal neovascularizations of any cause. 5. had prior intravitreal anti-VEGF or intravitreal/periocular corticosteroid treatment of CRVO. 6. have concomitant use of corticosteroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). 7. have a history of radial optic neurotomy. 8. have a history of vitreo-retinal surgery in the study eye or anticipated surgery within the next 12 months. 9. have a history of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with topical anti-glaucomatous medication). 10. show presence of vitreoretinal traction or epiretinal gliosis affecting central vision. 11. had any intraocular surgery (cataract surgery or Yag Capsulotomy) within 3 months prior to enrolment. 12. present with neovascular glaucoma, iris neovascularization, vitreous hemorrhage in the study eye. 13. have aphakia or absence of the posterior capsule in the study eye. 14. show uncontrolled arterial hypertension and/or diabetes mellitus. 15. have a history of myocardial infarction or stroke within 6 months prior to enrolment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Explore whether intravitreal ranibizumab is an effective, safe and convenient treatment for patients with macular edema due to central retinal vein occlusion. Aim of the study is to increase the visual acuity by 15 EDTRS letters in 50% of the patients.;Secondary Objective: Anzahl der Patienten/Patientinnen mit Visusverlust um mehr als 15 ETDRS Buchstaben, Anzahl der Patienten/ Patientinnen mit Anstieg um 15 Symbolen an den Pelli Robson Charts, Veränderung der zentralen Netzhautdicke mittels OCT; Veränderungen der Scores des NEI-VFQ-25 Fragebogens;Primary end point(s): To evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab. | — |
Countries
Austria
Outcome results
None listed