Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

Study Overview
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Brief Summary
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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.

Official Title
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Ranibizumab for Branch Retinal Vein Occlusion Associated Macular Edema Study (RABAMES)

Conditions
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Macular Edema

Intervention / Treatment
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* Drug: Ranibizumab
* Procedure: Laser photocoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>laser photocoagulation to the retina at the area of edema | Procedure: Laser photocoagulation<br>* laser photocoagulation to the retina at the area of edema<br>|
| Experimental: 2<br>intravitreal injection of ranibizumab | Drug: Ranibizumab<br>* intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8<br>* Other names: Lucentis;Procedure: Laser photocoagulation<br>* laser photocoagulation to the retina at the area of edema<br>|
| Experimental: 3<br>laser photocoagulation to the retina at the area of edema and intravitreal injection of ranibizumab | Drug: Ranibizumab<br>* intravitreal injection of 0.5 mg ranibizumab after randomisation, at week 4 and 8<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in best spectacle-corrected visual acuity (BSCVA) |  | from baseline to month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Mean change in central macular thickness (by OCT) |  | from month 3 to 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular edema secondary to branch retinal vein occlusion