Efficacy and safety of two different treatment patterns of ranibizumab in patients with wet AMD

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 644

Inclusion Criteria

1. Written informed consent must be obtained before any study related procedure is performed.

2. Male or female patients, =50 years of age.

Inclusion criteria for the study eye at Screening:
3. Visual impairment predominantly due to nAMD.

4. Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography

5. Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT

6. CNV or sequelae of the CNV (i.e., 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 must be = 78 and = 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320)

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 258
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 386

Exclusion Criteria

Exclusion criteria for systemic medical history and conditions at Screening:
1. Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
2. Stroke or myocardial infarction within 3 months prior to Screening.
3. Presence of uncontrolled systolic blood pressure > 160 mmHg or diastolic blood pressure > 100
mmHg.
4. Known hypersensitivity to the investigational drug (ranibizumab or any component of the Ranibizumab formulation) or to drugs of similar chemical class or to fluorescein or any other component of fluorescein formulation.

Exclusion criteria for ocular medical history and conditions at Screening:
5. Any active periocular or ocular infection or inflammation in both eyes.
6. Uncontrolled glaucoma (intraocular pressure [IOP] =30 mm Hg on medication or according to investigator’s judgment) in the study eye.
7. Atrophy or fibrosis involving the center of the fovea in the study eye.
8. History of focal/grid laser photocoagulation with involvement of the macular area at any time in the study eye.
9. Ocular disorders in the study eye (i.e. retinal detachment, pre-retinal membrane of the macula or cataract with significant impact on visual acuity) at the time of enrollment that may confound interpretation of study results and compromise visual acuity.
10. Presence of amblyopia or ocular disorders with final best corrected vision <20/200 or amaurosis in the fellow eye.

Exclusion criteria for prior or current ocular treatment at Screening:
11. History of treatment with any anti-angiogenic drugs (including any anti-VEGF agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye.
12. History of intravitreal treatment with corticosteroids within 6 months prior to Screening in the study eye.
13. History of intra-ocular surgery within 3 months in the study eye prior to the Screening. Exclusion criteria for prior or current systemic medication at Screening:
14. Use of other investigational drugs (excluding vitamins, minerals) within 30 days or 5 half-lives from Screening, whichever is longer.
15. Use of any systemic anti-VEGF drugs within 3 months prior to Screening (e.g., bevacizumab [Avastin®], ziv-aflibercept [Zaltrap®]).
16. Current or planned use of systemic medications know to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine (Plaquenil®), tamoxifen, henothiazines and ethambutol.

Exclusion criteria for patient at Screening:
17. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after contraception and until the termination of gestation, confirmed by a positive hCG laboratory test.
18. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include:
• Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
• Female sterilization (have had surgical bilateral oophorectomy with or without hystere

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials