Trial Outcomes & Findings for A Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV) (NCT NCT02397954)

Results Overview

Number of participants with \>15 ETDRS letter loss (with calculated percentage)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

3 Months

Results posted on

2025-03-20

Participant Flow

Participant milestones

Participant milestones
Measure	Zimura + Anti-VEGF Zimura 1mg/eye intravitreal injection + Anti-vascular endothelial growth factor (VEGF) (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Establish the Safety and Tolerability of Zimura™ (Anti-C5 Aptamer) in Combination With Anti-VEGF Therapy in Subjects With Idiopathic Polypoidal Choroidal Vasculopathy (IPCV)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Zimura + Anti-VEGF n=4 Participants Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Age, Continuous	74.5 years STANDARD_DEVIATION 6.03 • n=5 Participants
Age, Customized Age · Adults 50-65	0 Participants n=5 Participants
Age, Customized Age · Adults >65-75	2 Participants n=5 Participants
Age, Customized Age · Adults >75	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 Months

Number of participants with \>15 ETDRS letter loss (with calculated percentage)

Outcome measures

Outcome measures
Measure	Zimura + Anti-VEGF n=4 Participants Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Number of Participants With >15 ETDRS Letter Loss at Month 3	0 Participants

PRIMARY outcome

Timeframe: 3 months

Number of Participants with Ophthalmic Adverse Events (with calculated percentage)

Outcome measures

Outcome measures
Measure	Zimura + Anti-VEGF n=4 Participants Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Number of Participants With Ophthalmic Adverse Events	3 Participants

PRIMARY outcome

Timeframe: 3 months

Number of Participants with Systemic Adverse Events (with calculated percentage)

Outcome measures

Outcome measures
Measure	Zimura + Anti-VEGF n=4 Participants Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Number of Participants With Systemic Adverse Events	1 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Month 3

Population: Limited sample size; all study participants were included in the analysis.

Mean change in central subfield retinal thickness from baseline at Month 3 as measured by SD-OCT

Outcome measures

Outcome measures
Measure	Zimura + Anti-VEGF n=4 Participants Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Mean Change in Central Subfield Retinal Thickness (SD-OCT) From Baseline at Month 3	-2.75 μm Interval -67.0 to 69.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Month 3

Regression and/or Elimination of Polyps from baseline to Month 3

Outcome measures

Outcome measures
Measure	Zimura + Anti-VEGF n=4 Participants Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Regression and/or Elimination of Polyps at Month 3	NA Polyps Data is not available due to the limited quality of the images

Adverse Events

Zimura + Anti-VEGF

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Zimura + Anti-VEGF n=4 participants at risk Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Infections and infestations Endophthalmitis	25.0% 1/4 • Number of events 1 • 3 Months

Other adverse events

Other adverse events
Measure	Zimura + Anti-VEGF n=4 participants at risk Zimura 1mg/eye intravitreal injection + Anti-VEGF (Avastin 1.25mg/eye or Lucentis 0.5mg/eye or Eylea 2mg/eye) intravitreal injection
Eye disorders Conjunctival haemorrhage	75.0% 3/4 • Number of events 4 • 3 Months
Gastrointestinal disorders Gastroesophageal reflux disease	25.0% 1/4 • Number of events 1 • 3 Months

Additional Information

Keith Westby

Ophthotech Corp

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.
Publication restrictions are in place

Restriction type: OTHER