EUCTR2012-005439-10-DE
Active, not recruiting
Phase 1
Re-treatment with intravitreal application of ranibizumab guided by morphological macular changes documented by optical coherence tomography (OCT) in patients with macular edema due to branch retinal vein occlusion
niversity of Leipzig Ritterstr. 26, 04109 Leipzig0 sites18 target enrollmentJuly 23, 2013
Conditionsmacular edema secondary to branch retinal vein occlusion (BRVO)MedDRA version: 18.1Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 100000004853MedDRA version: 18.1Level: LLTClassification code 10038906Term: Retinal vein branch occlusionSystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- macular edema secondary to branch retinal vein occlusion (BRVO)
- Sponsor
- niversity of Leipzig Ritterstr. 26, 04109 Leipzig
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Completed up\-load phase of ranibizumab treatment (at least 3 monthly intravitreal injections) due to macular edema secondary to branch retinal vein occlusion with presence of recurrence of macular edema detected by optical coherence tomography (OCT) without decrease of BCVA score more than 3 ETDRS letters when compared with BCVA on day of 3rd ranibizumab application
- •2\.BCVA score in the study eye between 20 letters (20/400\) and 78 letters (20/32\) measured in ETDRS chart and foveal thickness \= 250 µm (measured by OCT) and prior to the first ranibizumab injection
- •3\.Age \= 18 years
- •4\.Written informed consent of the patient
- •5\.The history of BRVO no longer than 8 months prior to the first ranibizumab injection
- •6\.Ability and willingness to attend all scheduled visits and assessments
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
Exclusion Criteria
- •1\.Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine\-Gass syndrome)
- •2\.Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
- •3\.An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
- •5\.Macular laser photocoagulation in the study eye prior to study entry
- •6\.Use of intraocular or periocular injection of steroids in the study eye prior to study entry
- •7\.Cataract surgery or Yttrium\-Aluminum\-Garnet (YAG) laser capsulotomy or any other intraocular surgery in the study eye within 3 months prior to study entry
- •8\.History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months prior to randomization
- •9\.The presence of active malignancy
- •10\.Pregnancy (positive pregnancy test) or lactation
- •11\.History of allergy to humanized antibodies or any component of the ranibizumab formulation
Outcomes
Primary Outcomes
Not specified
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