Trial Outcomes & Findings for Ranibizumab In Pigment Epithelium Tears Secondary To Age-Related Macular Degeneration Study (NCT NCT01914159)

NCT ID: NCT01914159

Last Updated: 2019-08-15

Results Overview

Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2019-08-15

Participant Flow

Participant milestones

Measure	Ranibizumab Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Ranibizumab n=24 Participants Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	76.8 years STANDARD_DEVIATION 5.2 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Region of Enrollment Germany	24 Participants n=5 Participants
Best-corrected visual acuity	50.3 ETDRS letters STANDARD_DEVIATION 18.7 • n=5 Participants
Central retinal thickness	571 µm STANDARD_DEVIATION 185 • n=5 Participants
Vision-related quality of life	79.0 NEI VFQ-25 score STANDARD_DEVIATION 10.8 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol

Outcome measures

Measure	Ranibizumab n=24 Participants Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Best-corrected Visual Acuity	52.9 ETDRS letters Standard Deviation 19.7

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	Ranibizumab n=24 Participants Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Retinal Morphology	436 µm Standard Deviation 171

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Ranibizumab n=24 Participants Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Vision-related Quality of Life	74.3 NEI VFQ-25 score Standard Deviation 13.9

Adverse Events

Ranibizumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ranibizumab n=24 participants at risk Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany): Monthly intravitreal injections
Eye disorders Increase of subretinal hemorrhage	4.2% 1/24 • Number of events 1

Additional Information

Tim U. Krohne, MD, FEBO

Dept of Ophthalmology, University of Bonn, Bonn, Germany

Phone: +49 228 287

Email: krohne@uni-bonn.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place