Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Following Sponsor reassessment, OPH2004 enrollment was stopped to initiate a new Zimura wet AMD trial, OPH2007, for treatment-naïve patients. Thus, only one patient was enrolled into and completed Study OPH2004.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective is to assess the safety of intravitreal (IVT) Zimura® administered in combination with anti-VEGF Therapy (AVASTIN®, EYLEA®, OR LUCENTIS®) in anti-VEGF treatment experienced subjects with neovascular age-related macular degeneration (AMD)
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avacincaptad Pegol and Avastin | Experimental | Participants receive three monthly Avastin treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol 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 Avacincaptad Pegol. |
|
| Avacincaptad Pegol and Lucentis | Experimental | Participants receive three monthly Lucentis treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol 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 Avacincaptad Pegol. |
|
| Avacincaptad Pegol and Eylea | Experimental | Participants receive three monthly Eylea treatments (Day 1, Month 1, and Month 2) followed by Avacincaptad Pegol 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 Avacincaptad Pegol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avacincaptad Pegol | Drug | Zimura 2 mg, administered by intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With >0 Letter Loss | 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. | Month 12 |
| Percentage of Participants With >0 Letter Loss | 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. | Month 18 |
| Percentage of Participants With >5 Letter Loss | 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. | Month 12 |
| Percentage of Participants With >5 Letter Loss | 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. | Month 18 |
| Percentage of Participants With >10 Letter Loss | 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. | Month 12 |
| Percentage of Participants With >10 Letter Loss | 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. | Month 18 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | IVERIC bio, Inc. | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| Link to plain language summary of the study on the Trial Results Summaries website | View source |
| Link to results and other applicable study documents on the Astellas Clinical Trials website | View source |
Not provided
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Following the Sponsor's reassessment of the Zimura development program, enrollment was stopped in this trial as the Sponsor determined that they would initiate a new Zimura wet AMD trial, the OPH2007 trial, for treatment-naïve patients. Therefore, a total of two patients were screened, one of whom was a screen failure. Thus, only one patient was enrolled into Study OPH2004.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With >0 Letter Loss | 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. | 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. | Posted | Number | percentage of participants | Month 12 |
|
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
Following the Sponsor's reassessment of the Zimura development program, enrollment was stopped in this trial as the Sponsor determined that they would initiate a new Zimura wet AMD trial, the OPH2007 trial, for treatment-naïve patients. Therefore, a total of two patients were screened, one of whom was a screen failure. Thus, only one patient was enrolled into Study OPH2004.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | IVERIC Bio, Inc. | 609-474-6755 | info@ivericbio.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2016 | Feb 16, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| C533178 | aflibercept |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Avastin | Drug | Avastin 1.25 mg, administered by intravitreal injection |
|
|
| Lucentis | Drug | Lucentis 0.5 mg, administered by intravitreal injection |
|
|
| Eylea | Drug | Eylea 2 mg, administered by intravitreal injection |
|
|
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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 |
| OG002 | 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 |
|
|
| Primary | Percentage of Participants With >0 Letter Loss | 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. | 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. | Posted | Number | percentage of participants | Month 18 |
|
|
|
| Primary | Percentage of Participants With >5 Letter Loss | 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. | 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. | Posted | Number | percentage of participants | Month 12 |
|
|
|
| Primary | Percentage of Participants With >5 Letter Loss | 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. | 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. | Posted | Number | percentage of participants | Month 18 |
|
|
|
| Primary | Percentage of Participants With >10 Letter Loss | 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. | 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. | Posted | Number | percentage of participants | Month 12 |
|
|
|
| Primary | Percentage of Participants With >10 Letter Loss | 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. | 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. | Posted | Number | percentage of participants | Month 18 |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |