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

• Sponsor: University Hospital, Bonn (Other)
• Overall Status: Completed
• CT.gov ID: NCT01914159
• Collaborator: (none)
• Enrollment: 24
• Locations: 3
• Arm: 1
• Duration (Months): 36.9
• Patients Per Site: 8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Mar 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ranibizumab	Drug: Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany); Monthly intravitreal injections

Outcome Measures

Primary Outcome Measures

1. Best-corrected Visual Acuity [12 months]

   Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol

Secondary Outcome Measures

1. Retinal Morphology [12 months]

   Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness

2. Vision-related Quality of Life [12 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Bonn, Department of Ophthalmology	Bonn		Germany	53127
2	University of München (LMU), Department of Ophthalmology	München		Germany	80336
3	Universityof Münster, Department of Ophthalmology	Münster		Germany	48149

Sponsors and Collaborators

• University Hospital, Bonn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Frank G. Holz, Director, Department of Ophthalmology, University of Bonn, University Hospital, Bonn
• ClinicalTrials.gov Identifier: NCT01914159
• Other Study ID Numbers: N-037.0156
• First Posted: Aug 1, 2013
• Last Update Posted: Aug 15, 2019
• Last Verified: Jul 1, 2019

• Additional relevant MeSH terms: Macular Degeneration; Ranibizumab

Study Results

Participant Flow

Arm/Group Title	Ranibizumab
Arm/Group Description	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Period Title: Overall Study
STARTED	24
COMPLETED	21
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	Ranibizumab
Arm/Group Description	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Overall Participants	24
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	0 0%
>=65 years	24 100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	76.8 (5.2)
Sex: Female, Male (Count of Participants)
Female	10 41.7%
Male	14 58.3%
Region of Enrollment (Count of Participants)
Germany	24 100%
Best-corrected visual acuity (ETDRS letters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ETDRS letters]	50.3 (18.7)
Central retinal thickness (µm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [µm]	571 (185)
Vision-related quality of life (NEI VFQ-25 score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [NEI VFQ-25 score]	79.0 (10.8)

Outcome Measures

1. Primary Outcome

Title	Best-corrected Visual Acuity
Description	Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ranibizumab
Arm/Group Description	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Measure Participants	24
Mean (Standard Deviation) [ETDRS letters]	52.9 (19.7)

2. Secondary Outcome

Title	Retinal Morphology
Description	Spectral-domain optical coherence tomography (SD-OCT) central retinal thickness
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ranibizumab
Arm/Group Description	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Measure Participants	24
Mean (Standard Deviation) [µm]	436 (171)

3. Secondary Outcome

Title	Vision-related Quality of Life
Description	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.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ranibizumab
Arm/Group Description	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Measure Participants	24
Mean (Standard Deviation) [NEI VFQ-25 score]	74.3 (13.9)

Adverse Events

Arm/Group Title	Ranibizumab
Arm/Group Description	Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
All Cause Mortality
	Ranibizumab
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Ranibizumab
	Affected / at Risk (%)	# Events
Total	0/24 (0%)
Other (Not Including Serious) Adverse Events
	Ranibizumab
	Affected / at Risk (%)	# Events
Total	1/24 (4.2%)
Eye disorders
Increase of subretinal hemorrhage	1/24 (4.2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.