Status:
COMPLETED
Effect of the Vitreous in Response to Intravitreal Injections of Ranibizumab for the Treatment of Diabetic Macular Edema
Lead Sponsor:
Centro Hospitalar do Porto
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18-85 years
Brief Summary
PURPOSE: To evaluate the effect of the vitreous in response to intravitreal (IV) injections of ranibizumab 0.5 mg/0.05ml (Lucentis; Genentech, South San Francisco, CA) for the treatment of diabetic ma...
Detailed Description
Patients will be included in two different groups according to the vitreous status: group 1 - non vitrectomized eyes; group 2 - vitrectomized eyes. Patients will be followed-up according to the standa...
Eligibility Criteria
Inclusion
- at least 18 years of age with either type 1 or type 2 diabetes mellitus;
- maximal central subfield foveal thickness (CSF) of at least 300μm (according to SD-OCT images - Spectral Domain Optical Coherence Tomography);
- BCVA of 20 to 80 letters, using ETDRS letters chart;
- ability to provide written informed consent.
Exclusion
- Pregnant or lactating;
- Epiretinal membrane (ERM) existence in the study eye;
- persistent posterior hyaloid adherence after vitrectomy for group 2;
- previous vitrectomy for group 1;
- history of other retinal vascular diseases in the study eye;
- LASER photocoagulation or intravitreal injections (IV) of anti-VEGF or systemic anti-VEGF or pro-anti-VEGF treatment and cataract surgery in the 6 months previously to the study eye inclusion;
- IV or peribulbar corticosteroid injections in the 6 months previously to study eye inclusion;
- history of IV of implant of fluocinolone acetonide in the study eye;
- vitreous hemorrhage or opacification in the study eye;
- active proliferative diabetic retinopathy in the study eye;
- active ocular inflammation or infection in either eye;
- aphakia in the study eye;
- other causes for macular edema, for example, after cataract surgery in the study eye;
- other causes of visual loss in the study eye;
- other diseases that may affect the course of macular edema in the study eye;
- uncontrolled glaucoma in either eye (intraocular pressure \> 24 mmHg with treatment);
- history of arterial thrombotic event in the previous 6 months;
- uncontrolled arterial hypertension (systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg);
- ward of the state.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2019
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04387604
Start Date
August 1 2017
End Date
March 1 2019
Last Update
May 14 2020
Active Locations (1)
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1
Hospital de Santo António
Porto, Portugal