Assessment of the suitability of serum VEGF level as diagnostic factor in macula edema under therapy with Lucentis® (ranibizumab)

Phase 1

Conditions: Central retinal vein occlusionRetinal vein occlusion
MedDRA version: 20.0Level: LLTClassification code 10007972Term: Central retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 20.0Level: PTClassification code 10038907Term: Retinal vein occlusionSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-004656-38-DE

Lead Sponsor: Prof. Dr. Karl-Heinz Emmerich

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

- Signed and dated Informed Consent prior to conduct of any study-related procedure
- Adult patient aged 18 years or more with the diagnosis of a decrease in visual acuity due to macula edema as a consequence of central retinal or retinal vein occlusion maximum 12 months prior to screening
- Central retinal thickness (CRT) > 250 µm
- Clear breaking media, possibility for good mydriasis and good cooperation of the patient in case of fundus photography
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

- Central retinal thickness = 250 µm
- Previous episode(s) of retinal vein occlusion at the study eye
- Active neovascularisation
- Aphakia of study eye (pseudo-aphake eyes are allowed)
- History of thrombotic or embolic disease
- Every history of a apoplectic insult or a transitory ischemic attack (TIA)
- Ocular or systemic anti-VEGF-treatment in the three months prior to screening
- History of pars plana vitrectomy
- Combined arterio-venuous occlusion
- Intraocular intervention within the 2 months prior to screening or planned intraocular intervention in the 12 months after screening
- Known vitreoretinal diseases,
- Intraocular pressure = 30 mm or uncontrolled glaucoma
- Every active infection at one of the two eyes
- Every ocular disease which in the opinion of the investigator would distort the study results
- Every relevant ocular disease which could affect the increase of the intraocular VEGF level
- Every relevant systemic disease which could potentially lead to an increase of the systemic VEGF level
- Known hyper sensivity or allergy to the study medication or any medication needed for diagnosis/therapy
- Diseases or conditions which in the opinion of the investigator exclude a subject's participation in the trial
- Participation in another clinical or non-intverventional study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Assessment of the suitability of serum VEGF level for the diagnostic differentiation between therapy responders (no macula edema in OCT) and therapy non-responders (persistence of macula edema, or reoccurrence of macula edema or increase of the macula edema at V2 of more than 50 micrometers) 12 weeks after start of the therapy.;Secondary Objective: - Time until first occurrence of a recurrent macula edema in the subgroup of patients with reoccurrence of macula edema or increase (more than 50 micrometer) of the macula edema present at baseline (V2) <br>- Course of VEGF level and change in comparison with baseline (Visit 2) over the entire study duration in the subgroups<br>- Course ;Primary end point(s): Serum VEGF level;Timepoint(s) of evaluation of this end point: 12 weeks after start of study therapy

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Time until occurrence of a recurrent macula edema as calculated from baseline (Visit 2) until reoccurrence of macula edema (upon improvement) or until first increase of at least 50 micrometers as compared withe baseline measurement based on OCT<br>- VEGF at time of investigation <br>- Visual acuity at time of investigation <br>- Macula thickness at time of investigation <br>- Vascularisation at time of investigation ;Timepoint(s) of evaluation of this end point: At time of investigation