Trial Outcomes & Findings for Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration (NCT NCT00517010)

Results Overview

Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

6 participants

Primary outcome timeframe

24 months

Results posted on

2016-07-11

Participant Flow

Participant milestones

Participant milestones
Measure	Lucentis Combined With Proton Beam Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
Overall Study STARTED	6
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Lucentis Combined With Proton Beam Irradiation in Treating Wet Age-related Macular Degeneration

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lucentis Combined With Proton Beam n=6 Participants Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
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	6 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Best corrected visual acuity	0.58 logMAR best corrected visual acuity STANDARD_DEVIATION 0.26 • n=5 Participants
Optical coherence tomography central macular thickness	335 microns STANDARD_DEVIATION 67 • n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Any ocular adverse event identified by eye examination during the study follow-up will be recorded and determined for possible or probable relation to study treatment.

Outcome measures

Outcome measures
Measure	Lucentis Combined With Proton Beam n=6 Participants Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
Incidence and Severity of Ocular Adverse Events	0 number of adverse events

SECONDARY outcome

Timeframe: 24 months

change in number of letter read correctly in study eye compared to the number of letters read correctly at baseline, i.e. BCVA (number of letters read correctly) at 24 months minus BCVA (number of letters read correctly) at baseline

Outcome measures

Outcome measures
Measure	Lucentis Combined With Proton Beam n=6 Participants Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
1. Change in BCVA From Baseline	2.8 change in number of letters Standard Deviation 26.4

Adverse Events

Lucentis Combined With Proton Beam

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

Susanna Park MD PhD

University of California Davis

Phone: 916-734-6074

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place