Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study (RIP)

Overview
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The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.

SEEK ID: https://fdm.digital-medicine.org/projects/3

Public web page: https://clinicaltrials.gov/study/NCT01914159

Organisms: No Organisms specified

NFDI4Health PIs: No PIs for this Trial Project

Trial Project start date: 1st Feb 2013

Trial Project end date: 31st Mar 2016

Extended Metadata (Nfdi4Health MDS 3.3)

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Resource classification(*)

Type of the resource : Study

Title(s)/name(s) of the Project

Title/name : Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study (RIP)
Language of the title/name : English

Acronym(s) of the Project

Acronym : RIP
Language of the acronym : English

Description(s) of the Project

Description : The Ranibizumab in Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration (RIP) Study is a prospective, multicenter, uncontrolled, interventional phase 2 clinical trial that investigates the effect of fixed monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma, Germany) on visual acuity and retinal morphology over a study period of 12 months in 30 patients.
Language of the description : English

Keyword(s) describing the Project

Keyword(*) : Retinal Degeneration

Keyword(*) : Retinal Diseases

Keyword(*) : Eye Diseases

Keyword(*) : Macular Degeneration

Keyword(*) : Angiogenesis Inhibitors

Keyword(*) : Angiogenesis Modulating Agents

Keyword(*) : Growth Substances

Keyword(*) : Physiological Effects of Drugs

Keyword(*) : Growth Inhibitors

Keyword(*) : Antineoplastic Agents

Keyword(*) : Ranibizumab

Language(s) of the project : English

Contributor(s) of the Project

Is it a personal or organisational contribution?(*) : Personal
Details about the contributing organisation(s)/institution(s)/group(s)
Contributor type(*) : Not specified
Funding identifier(s) : Not specified
Name of the organisation/institution/group(*) : Rheinische Friedrich-Wilhelms-University Bonn represented by the Faculty of Medicine of the University of Bonn represented by the Dean of the Faculty of Medicine, Department of Ophthalmology
Details about the contributing person(s)
Contributor type(*) : Principal investigator
Given name(*) : Frank G.
Family name(s)(*) : Holz
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified
Email address : Not specified
Phone number : Not specified
Organisation(s) associated with the contributor
Name(*) : Not specified
Address : Not specified
Web page : Not specified
Digital identifier(s)
Identifier(*) : Not specified
Scheme(*) : Not specified

Alternative identifiers

Type of the registry(*) : Not specified
Identifier(*) : Not specified

Includes chronic diseases? : true

Characteristics of the Project

Is it an interventional or non-interventional Project? : Non-interventional
Specification of the type of the Project
Interventional Project type : []
Non-interventional Project type : []
Primary health condition(s) or disease(s) considered in the Project
Primary health condition or disease name(*) : Age-Related Macular Degeneration
Terminology/classification(*) : Not specified
Code of the health condition or disease : Not specified
Groups of diseases or conditions(*)
Which groups of diseases or conditions were the data collected on? : Diseases of the eye and adnexa (VII)
On which diseases or conditions were the data collected? : []
Collects mortality data? : No
Administrative information about the Project
Status of the ethics committee approval : Not specified
Overall Project status : Completed: Recruitment, data collection, and data quality management completed normally
Participants enrolled by invitation? : Not specified
Start date : 1 February 2013
End date : 31 March 2016
Mono- or multicentric? : Multicentric
Number of centers : 3
One or more data providers? : Not specified
Number of data providers : Not specified
Primary subject(*) : Person
Eligibility criteria for Project participants
Eligibility criteria: Minimum age
Minimum eligible age(*) : 50
Unit of age(*) : Years
Eligibility criteria: Maximum age
Maximum eligible age(*) : Not specified
Unit of age(*) : Not specified
Eligible gender : Male, Female, Diverse
Inclusion criteria : Diagnosis of a pigment epithelial tear secondary to age-related macular degeneration, Written informed consent
Exclusion criteria : Time of diagnosis more than 6 months before study recruitment, Ocular surgery of the study eye within 1 month before study recruitment, Extensive subretinal fibrosis or retinal atrophy of the study eye, Significant opacification of optical media of the study eye, Uncontrolled glaucoma of the study eye, Active ocular inflammation of the study eye, Best-corrected visual acuity of the contralateral eye below 20/200, Concurrent ocular or systemic therapy with other vascular endothelial growth factor (VEGF)-inhibitory drugs
Population of the Project(*)
Coverage : National
Country(ies) : Germany
Region(s) and/or city(ies) : Not specified
Interventions of the Project
Name of the intervention(*) : fixed monthly intravitreal injections of ranibizumab
Type of the intervention : Drug (including placebo)
Additional information about the intervention : Not specified
Name(s) of the arm(s) associated with the given intervention : Not specified
Exposures of the Project
Name of the exposure : Not specified
Type of the exposure : Other
Additional information about the exposure : Not specified
Name(s) of the group(s) associated with the given exposure : Not specified
Outcome measures in the Project
Name of the outcome measure(*) : Best-corrected Visual Acuity
Description of the outcome measure : Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
Type of the outcome measure : Primary
Time point(s) of assessment : 12 months
Name of the outcome measure(*) : Retinal Morphology
Description of the outcome measure : Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
Type of the outcome measure : Secondary
Time point(s) of assessment : 12 month
Name of the outcome measure(*) : Vision-related Quality of Life
Description of the outcome measure : National Eye Institute Visual Function Questionaire 25-item version (NEI VFQ-25) 0 to 100 scale, where 100 represents the best possible score and 0 represents the worst Reference: Mangione CM et al. Arch Ophthalmol 2001 Jul;119(7):1050-8.
Type of the outcome measure : Secondary
Time point(s) of assessment : 12 month
Additional information about the Project : Not specified
Additional assessments/measurements in the Project : []
Data sharing strategy of the Project(*)
Is it planned to share the data?(*) : Not specified
Supporting documents available in addition to the data : []
When and for how long will the data be available? : Not specified
Criteria for data access : Not specified
Additional information about data sharing : Not specified
DataSHIELD/Opal infrastructure available? : Not specified
Link to data request application : Not specified
Web page with additional information about data sharing : Not specified
Record linkage possible? : Not specified
Non-interventional aspects of the Project
Temporal design : []
Target follow-up duration of the Project
Target follow-up duration(*) : Not specified
Unit of time(*) : Not specified
Number of follow-ups conducted : Not specified
Biosamples retained in a biorepository : None retained
Specific types of retained biosamples : Not specified
Interventional aspects of the Project
Numerical phase : Phase-2
Masking of intervention(s) assignment
Masking implemented? : Not specified
Who is masked? : []
Additional information about masking : Not specified
Type of allocation of participants to an arm : Not applicable (for single-arm trials)
Off-label use of a drug product : Not specified

Annotated Properties

Topic annotations

Medicines research and development

Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study (RIP)

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