Variation of choroidal Thickness 15 days after the first ranibizumab intravitreal injection in naïve patients WIth Neovascular age-related macular degeneration: pilot Study. –

• Conditions: Wet age-related macular degeneration; MedDRA version: 16.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 100000004853; Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

• Registration Number: EUCTR2013-005091-17-IT
• Lead Sponsor: POLICLINICO GEMELLI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-20
• Last Update Posted: 19 January 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Male or female patients > 50 years of age who have signed an informed consent before any assessment is performed
2.Visual impairment predominantly due to neovascular AMD (wet AMD).
3.Choroidal neovascularization (CNV) classic or minimally classic; in the new CNV classification type II.
4.Naïve eyes with no history of intravitreal injection before the study.
5.Active, newly diagnosed, untreated, angiographically documented CNV lesion (ie leakage on fluorescein angiography plus intraretinal, subretinal or sub RPE fluid on OCT) secondary to AMD.
6.CNV or sequelae of the CNV (ie, pigment epithelium detachment, subretinal or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal, sub-RPE or intraretinal fluid) involving the center of the fovea.
7.The total area of fibrosis comprising less than 50% of the lesion area.
8.BCVA score at Baseline between 78 and 23 letters as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at 4 meters, inclusively (approximate Snellen equivalent of 20/32 and 20/320).
If both eyes are eligible at Baseline, the investigator will decide the study eye based on his/her clinical judgment. The study eye will be treated with ranibizumab, according to the criteria defined for each treatment group.

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 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 19

Exclusion Criteria

1.History of hypersensitivity to drugs of similar chemical classes of ranibizumab.
2.Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity while on treatment
3.Active intraocular inflammation (grade trace or above) in either eye.
4.Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye.
5. History of uveitis in either eye.
6.Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques.
7.Ocular disorders in the study eye that may confound interpretation of results, compromise visual acuity or require medical or surgical intervention during the program period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause (e.g. ocular histoplasmosis or pathologic myopia).
8.Uncontrolled glaucoma in either eye (IOP = 30 mmHg on medication or according to investigator’s judgment).
9. Neovascularization of the iris in either eye.
10.Evidence of vitreomacular traction in either eye.
11. Patients who are monocular or have a BCVA score in the non-study eye (fellow eye) = 24 letters (approximate Snellen equivalent of 20/320) at Basal Visit.
12.Any use of eye drops for ocular disease as anti-glaucomatous or antinflammatory drugs.
13.History of eye surgery procedure (i.e. cataract surgery, vitrectomy or other surgery in the last 3 months).
14.Significant lens opacities.
15.History of myocardial infarction or cerebral vascular diseases.
16. Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, aflibercept.) before the enrollment.
17.Known hypersensitivity to Ranibizumab or any component of the Ranibizumab formulation.
18.Pregnant or nursing (lactating) women.
19.Inability to comply with study procedures.

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 choroidal thickness after the first study drug administration in naïve wAMD patients.;Secondary Objective: •To investigate the type of regression of choroidal thickness after ranibizumab treatment on its basal value.<br>•To investigate correlation between BCVA and choroidal thickness after ranibizumab treatment<br>;Primary end point(s): variation of choroidal thickness from baseline visit (first ranibizumab injection) to day 15.;Timepoint(s) of evaluation of this end point: 15 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •Type of regression (linear, squares, cubic, etc.) of choroidal thickness measured at different times ( 30, 60, 90 days) after ranibizumab treatment on its basal value.<br>•Correlation between BCVA and choroidal thickness measured at 30, 60 and 90 days after ranibizumab treatment.<br>;Timepoint(s) of evaluation of this end point: 30, 60, 90 days