Clinical trial to evaluate the safety and efficacy of intravitreal ranibizumab in patients with choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia.
- Conditions
- Patients with subfoveal or juxtafoveal choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia (angioid streaks, pseudohistoplasmosis, inflammatory chorioretinal diseases and idiopathic lesions).MedDRA version: 13.1Level: LLTClassification code 10060837Term: Choroidal neovascularizationSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2009-014612-34-PT
- Lead Sponsor
- AIBILI - Association for Innovation and Biomedical Research on Light and Image
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1.Male or female patients 18 years old or greater.
2.Diagnosis of active primary or recurrent choroidal neovascularization (CNV) secondary to other causes than Age-related Macular Degeneration or Pathological Myopia. Patients previously receiving CNV therapy with verteporfin photodynamic therapy and/or intravitreal steroids in the study eye will be eligible to participate in the study if continued treatment is needed for their CNV due to FA leakage and/or re-accumulation of retinal fluid (e.g. re-accumulation of sub retinal intra retinal or sub-pigment epithelium fluid at least 1 month after last treatment will be considered eligible).
3.The total lesion area must be = 12 disc areas.
4.Best-corrected Visual Acuity > 20/400 (20 letters in the ETDRS Chart) in the study eye.
5.Expectation by the investigator that patient will potentially benefit from ranibizumab treatment.
6.Willing and able to give written informed consent according to legal requirements, and who have signed the consent form prior to initiation of any study procedure.
7.Willing and able to comply with all study procedures.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
1.Previous intravitreal treatment in the study eye with bevacizumab, ranibizumab or pegaptanib.
2.Laser photocoagulation, treatment with intravitreal steroids or verteporfin photodynamic therapy (Visudyne®) in the study eye 3 months preceding Day 1.
3.Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
4.History of surgical intervention in the study eye within 6 months preceding Day 1.
5.Previous participation in any studies of investigational drugs 3 months preceding Day 1(excluding vitamins and minerals).
6.Ocular disorders in the study eye that may confound interpretation of study results, including exudative age-related macular degeneration, pathological myopia, retinal detachment, vitreous hemorrhage or macular hole or persistent macular edema due to uveitis or other inflammatory diseases.
7.Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period.
8.Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation.
9.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive laboratory test (> 5mIU/mL).
10.Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant UNLESS they are: women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner; women whose partners have been sterilized by vasectomy or other means using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices - IUDs). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable.
Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and the efficacy of ranibizumab 0.5 mg intravitreal injection in the treatment of choroidal neovascularization secondary to other causes than Age-related Macular Degeneration and Pathological Myopia. ;Secondary Objective: To evaluate the efficacy and safety of the treatment using:<br>?Best-corrected Visual Acuity<br>?Number of treatments per year per patient<br>?Mean change in retinal thickness as assessed with OCT <br>?Ocular and systemic side effects.<br><br>;Primary end point(s): Best-corrected visual acuity changes. <br>;Timepoint(s) of evaluation of this end point: Month 3, Month 6, Month 9 and Month 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Best-corrected visual acuity gain or loss = 3 ETDRS lines (15 letters)<br>- Retinal Thickness changes assessed with OCT<br>- Number of treatments<br>- Ocular and systemic side effects;Timepoint(s) of evaluation of this end point: Month 3, Month 6, Month 9 and Month 12