Macular Edema
Conditions
Keywords
Macular edema secondary to branch retinal vein occlusion
Brief summary
The primary objective of this pilot study is to compare the functional and anatomic outcomes of chronic macular edema secondary to branch retinal vein occlusion (BRVO) treated with argon laser photocoagulation versus intravitreal ranibizumab (Lucentis®) injection versus a combination of both.
Interventions
DRUGRanibizumab
intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8
PROCEDURELaser photocoagulation
laser photocoagulation to the retina at the area of edema
Sponsors
Norvartis Pharma, Nuremberg, Germany
Coordination center for clinical studies, Mainz, Germany
Klinikum Ludwigshafen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years and older with chronic (\> 3months, \< 18 months) macular edema secondary to branch retinal vein occlusion * Patients who at baseline have a BSCVA in the study eye between 20/320 and equivalent to 20/40, using an ETDRS chart measured at 4 meters * Patients who at baseline have a chronic macular edema (\> 3 months) in the study eye with the following characteristics as determined by fluorescein angiography: * Evidence that the macular edema extends under the geometric center of the foveal avascular zone. * Evidence that the edema is only secondary to BRVO (no other relevant ocular diseases, e.g. uveitis). * Patients who at baseline have a chronic macular edema (\> 3 months) in the study eye with the following characteristics as determined by optical coherence tomography (OCT 3): * Evidence that central macular thickness is \> 225 μm. * Ability of subject to understand character and individual consequences of clinical trial. * Signed and dated informed consent of the subject must be available before start of any specific trial procedures. * For women with childbearing potential, adequate contraception (negative pregnancy test result, serum or urine at trial entry, after treatment and at end of study). * Only one eye of a patient may be included to this trial.
Exclusion criteria
* Patients who at baseline * Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, neovascular age-related macular degeneration, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, and others) * Have a relevant systemic disease which may be associated with increased systemic VEGF levels (namely all malignancies) * Had previous treatment for macular edema (laser, triamcinolone, vitrectomy) * Pregnancy and lactation. * History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product. * Participation in other clinical trials within the last 3 months. * Medical or psychological condition that would not permit completion of the trial or signing of informed consent. * Arterial hypertension refractory to medical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in best spectacle-corrected visual acuity (BSCVA) | from baseline to month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in BSCVA | from baseline to month 3 |
| Proportion of patients who gain ≥ 5, 10, 15 letters of BSCVA | from baseline to month 3 and 6 |
| Proportion of patients who lose less than 15 letters of BCVA | from baseline to month 3 and 6 |
| Change in area and intensity of leakage | from baseline to month 1, 3 and 6 |
| Mean change in central macular thickness (by OCT) | from baseline to month 1, 3 and 6 |
Countries
Germany
Outcome results
None listed