Macular Edema
Conditions
Interventions
This is a Phase II clinical trial that will enroll 100 volunteer participants. Block randomization will be performed in blocks of 4 participants (2 per group). In cases of bilateral involvement, only
Sponsors
Universidade Federal de Pernambuco
Clínica Oftalmológica Zona Sul
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: DAge 18 years or older; male or female gender; diagnosis of neovascular age-related macular degeneration or clinically significant diabetic macular edema in one or both eyes, as defined by the Early Treatment Diabetic Retinopathy Study guidelines; best-corrected visual acuity between 0.3 and 1.3 LogMAR, inclusive; axial length between 22 and 25 mm, inclusive, as measured by optical low-coherence reflectometry (Lenstar LS900™, Haag-Streit™, Switzerland); central subfield thickness of 300 µm or greater, as measured by spectral-domain optical coherence tomography (Cirrus®, Zeiss™, Germany)
Exclusion criteria
Exclusion criteria: Any treatment for neovascular age-related macular degeneration or clinically significant diabetic macular edema within the preceding 4 months; panretinal photocoagulation performed within the preceding 4 months; any ocular surgery performed within the preceding 4 months, history of pars plana vitrectomy, history of open-angle glaucoma or corticosteroid-induced ocular hypertension requiring treatment with anti-glaucoma or ocular hypotensive medications, intraocular pressure > 21 mmHg, known hypersensitivity to any substance used in the procedure, presence of tractional retinal detachment; inability or unwillingness to provide informed consent
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure 30 minutes and 28 days after the injection.;Change in central macular thickness, measured by spectral-domain optical coherence tomography, between before the injection and 28 days after.;Change in the best corrected visual acuity, measured by spectral-domain optical coherence tomography, between before the injection and 28 days after. | — |
Primary
| Measure | Time frame |
|---|---|
| Relative change in intraocular pressure between 15 minutes before the intravitreal injection and 5 minutes after the injection. | — |
Countries
Brazil
Contacts
Public ContactRodrigo Lira
Universidade Federal de Pernambuco
Outcome results
None listed