Trial Outcomes & Findings for Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD (NCT NCT05571267)
NCT ID: NCT05571267
Last Updated: 2025-03-13
Results Overview
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Month 12
Results posted on
2025-03-13
Participant Flow
Participant milestones
| Measure |
Zimura and Avastin
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Zimura in Combination With Anti-VEGF Therapy in Patients With Neovascular AMD
Baseline characteristics by cohort
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
Total
n=1 Participants
Total of all reporting groups
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|---|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
—
|
1 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Outcome measures
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
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|---|---|---|---|
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Percentage of Participants With >0 Letter Loss
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 18Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
Vision testing is performed using retroilluminated modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Outcome measures
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
|---|---|---|---|
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Percentage of Participants With >0 Letter Loss
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Outcome measures
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
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|---|---|---|---|
|
Percentage of Participants With >5 Letter Loss
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 18Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Outcome measures
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
|---|---|---|---|
|
Percentage of Participants With >5 Letter Loss
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 12Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 12 from Day 1 was assessed.
Outcome measures
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
|---|---|---|---|
|
Percentage of Participants With >10 Letter Loss
|
0 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Month 18Population: Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin arm. There were no participants in the Zimura and Lucentis arm and there were no participants in the Zimura and Eylea arm.
Vision testing is performed using retroilluminated modified Ferris-Bailey ETDRS charts at 4 meters. Observed VA loss at Month 18 from Day 1 was assessed.
Outcome measures
| Measure |
Zimura and Avastin
n=1 Participants
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
|---|---|---|---|
|
Percentage of Participants With >10 Letter Loss
|
0 percentage of participants
|
—
|
—
|
Adverse Events
Zimura and Avastin
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Zimura and Lucentis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Zimura and Eylea
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Zimura and Avastin
n=1 participants at risk
Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Avastin and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Avastin: Avastin 1.25 mg, administered by intravitreal injection
|
Zimura and Lucentis
Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Lucentis and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Lucentis: Lucentis 0.5 mg, administered by intravitreal injection
|
Zimura and Eylea
Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Zimura administered on the same day. All participants will receive treatment every 3 months for a total of 18 months. If there is a loss of visual acuity during the intervening visits, participants may be retreated with Eylea and Zimura. Zimura: Zimura 2 mg, administered by intravitreal injection Eylea: Eylea 2 mg, administered by intravitreal injection
|
|---|---|---|---|
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Infections and infestations
nasopharyngitis
|
100.0%
1/1 • Number of events 1 • Starting on Day 1, after first dose of trial drug, and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later, up to approximately 18 months.
Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin treatment arm. There were no participants included in the Zimura and Lucentis arm and there were no participants included in the Zimura and Eylea arm.
|
—
0/0 • Starting on Day 1, after first dose of trial drug, and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later, up to approximately 18 months.
Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin treatment arm. There were no participants included in the Zimura and Lucentis arm and there were no participants included in the Zimura and Eylea arm.
|
—
0/0 • Starting on Day 1, after first dose of trial drug, and continuing until 30 days after the last dose or until the last follow-up visit required by the protocol, whichever comes later, up to approximately 18 months.
Only one patient was enrolled into Study OPH2004. This participant was included in the Zimura and Avastin treatment arm. There were no participants included in the Zimura and Lucentis arm and there were no participants included in the Zimura and Eylea arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual site or investigator may publish or present any results from the trial until a joint, multi-center publication of the trial results is made by Sponsor in conjunction with various participating investigators and appropriate sites contributing data and comments. Subsequently, individual investigators may request to publish or present results from the trial; however approval will be at the sole discretion of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER