Ranibizumab for the Treatment of Choroidal Neovascularisa... | NCT01037348

ID	Type	Description	Link
2009-014854-14	EudraCT Number

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Dec 21, 2009

First Submission Date that Met QC Criteria

Dec 22, 2009

First Posted Date

Dec 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2016

Last Update Posted Date

Apr 19, 2016Estimated

Description Module

Brief Summary

This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria.

Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Label	Type	Description	Intervention Names
ranibizumab 0.5mg	Experimental		Drug: ranibizumab 0.5mg

Name	Type	Description	Arm Group Labels	Other Names
ranibizumab 0.5mg	Drug		ranibizumab 0.5mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The difference from baseline in mean Best Corrected Visual Acuity (BCVA)		12 months

Secondary Outcomes

Measure	Description	Time Frame
Mean change in BCVA from baseline		6 months
Mean change in Central retinal Thickness (CRT) from baseline		6 and 12 months
Percentage of patients gaining ≥ 15 letters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female outpatients of any race, aged 18 years or older
Diagnosis of active primary or recurrent subfoveal or juxtafoveal CNV secondary to PM
Diagnosis of high myopia of at least -6 dioptres in the study eye spherical equivalent. For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye must have been at least -6 dioptres
Patients who have a BCVA score between 78 and 24 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS)-like grading charts (approximately 6/9 - 6/96 Snellen equivalent)
Patients must give fully informed consent and be willing and able to comply with all study procedures

Exclusion Criteria:

History of any surgical intervention in the study eye within two months preceding screening
Previous macular laser photocoagulation, treatment with intravitreal steroids, verteporfin with photodynamic therapy (Visudyne®) or anti-VEGF agents ranibizumab, bevacizumab or pegaptanib sodium (Macugen®) in the study eye
Previous treatment with intravenously administered bevacizumab (Avastin®)
Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
History of allergic reaction to fluorescein
Concurrent use of systemic anti-VEGF agents

Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Bristol		BS1 2LX	United Kingdom
Novartis Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24001532	Derived	Tufail A, Narendran N, Patel PJ, Sivaprasad S, Amoaku W, Browning AC, Osoba O, Gale R, George S, Lotery AJ, Majid M, McKibbin M, Menon G, Andrews C, Brittain C, Osborne A, Yang Y. Ranibizumab in myopic choroidal neovascularization: the 12-month results from the REPAIR study. Ophthalmology. 2013 Sep;120(9):1944-5.e1. doi: 10.1016/j.ophtha.2013.06.010. No abstract available.

ID	Term
D020256	Choroidal Neovascularization
D047728	Myopia, Degenerative

ID	Term
D015862	Choroid Diseases
D014603	Uveal Diseases
D005128	Eye Diseases
D009389	Neovascularization, Pathologic
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009216	Myopia
D012030	Refractive Errors

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins