Trial Outcomes & Findings for Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy (NCT NCT01325181)

Results Overview

number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

34 participants

Primary outcome timeframe

12 months

Results posted on

2013-05-27

Participant Flow

Participant milestones

Participant milestones
Measure	Low-fluence PDT	Ranibizumab
Overall Study STARTED	18	16
Overall Study COMPLETED	18	14
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low-fluence PDT n=18 Participants	Ranibizumab n=16 Participants	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	51.4 years STANDARD_DEVIATION 8.2 • n=5 Participants	48.9 years STANDARD_DEVIATION 7.5 • n=7 Participants	50.8 years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment Korea, Republic of	18 participants n=5 Participants	16 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: All study eyes were analyzed using intention to treat principle and the last observation forward method

number of participants who achieved complete resolution of subretinal fluid on OCT without rescue treatment until the end of the study

Outcome measures

Outcome measures
Measure	Low-fluence PDT n=18 Participants	Ranibizumab n=16 Participants
Number of Participants That Achieved Complete Resolution of Subretinal Fluid on OCT Without Rescue Treatment	16 participants	2 participants

SECONDARY outcome

Timeframe: 12 months

the changes from baseline in logMAR BCVA throughout the follow-up period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

the change from baseline in central foveal thickness measured by OCT throughout the follow-up period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

number of participants who showed fluorescein leakage after primary or rescue treatment throughout the follow-up period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

change from baseline in the status of choroidal perfusion and hyperpermeability on indocyanine green angiography throughout the follow-up period

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

number of participants who underwent rescue treatment: ranibizumab injections for the low-fluence PDT group and low-fluence PDT for the ranibizumab group

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

number of participants with adverse event throughout the follow-up period including procedure and drug-related adverse events

Outcome measures

Outcome data not reported

Adverse Events

Low-fluence PDT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ranibizumab

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

Jang Won Heo

Seoul National University Hospital

Phone: 82220720836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place