Trial Outcomes & Findings for A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study) (NCT NCT01115556)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

9 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2018-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Lucentis 2.0 mg Lucentis (ranibizumab) 2.0 mg	Lucentis 0.5 mg Lucentis (ranibizumab) 0.5 mg
Overall Study STARTED	7	2
Overall Study COMPLETED	7	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Evaluate the Role of High-dose Ranibizumab (2.0mg) in the Management of AMD in Patients With Persistent/Recurrent Macular Fluid Less Than 30 Days Following Treatment With Intravitreal Anti-VEGF Therapy (the LAST Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lucentis 2.0 mg n=7 Participants Lucentis (ranibizumab) 2.0 mg	Lucentis 0.5 mg n=2 Participants Lucentis (ranibizumab) 0.5 mg	Total n=9 Participants Total of all reporting groups
Age, Customized	80.1 years STANDARD_DEVIATION 5.4 • n=99 Participants	88.0 years STANDARD_DEVIATION 0.0 • n=107 Participants	82.0 years STANDARD_DEVIATION 5.8 • n=206 Participants
Sex: Female, Male Female	5 Participants n=99 Participants	1 Participants n=107 Participants	6 Participants n=206 Participants
Sex: Female, Male Male	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Lucentis 2.0 mg n=7 Participants Lucentis (ranibizumab) 2.0 mg	Lucentis 0.5 mg n=2 Participants Lucentis (ranibizumab) 0.5 mg
Mean Change in Visual Acuity (VA) From Baseline at Month 6	6.1 ETDRS Letters Standard Deviation 3.7	2.0 ETDRS Letters Standard Deviation 0.0

SECONDARY outcome

Timeframe: one year

* Mean change in Visual Acuity (VA) from Baseline at Month 12 * Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12 * Mean change in leakage as determined by FA at Months 6 and 12 * Mean number of ranibizumab injections at Months 6 and 12 * Mean time to first re-treatment following the initial 3 monthly loading doses * Mean duration of fluid-free interval * Safety and tolerability of 2.0mg using the incidence and severity of adverse events

Outcome measures

Outcome measures
Measure	Lucentis 2.0 mg n=7 Participants Lucentis (ranibizumab) 2.0 mg	Lucentis 0.5 mg n=2 Participants Lucentis (ranibizumab) 0.5 mg
Mean Change in Visual Acuity (VA) From Baseline at Month 12	4.1 ETDRS Letters Standard Deviation 4.5	3.0 ETDRS Letters Standard Deviation 0.0

Adverse Events

Lucentis 2.0 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lucentis 0.5 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

K. Bailey Freund, MD (or Galyna Ganieva, Research Manager)

Vitreous Retina Macula Consultants of New York

Phone: 212-861-9797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place