A Phase 2 interventional study of Fovista® and bevacizumab in Age-Related Macular Degeneration, sponsored by Ophthotech Corporation. Terminated at 24 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by Ophthotech Corporation · Phase 2, Interventional, and Treatment
To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.
60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:
Subjects will be stratified by lesion size (≤2 DA vs. >2 DA).
Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.
When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 63 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Ophthotech Corporation is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Drug: Fovista® · Drug: bevacizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Drug: Fovista® · Drug: ranibizumab
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Drug: Fovista® · Drug: aflibercept
Also known as: Avastin®
Also known as: Lucentis®
Also known as: Eylea®
Total Numer of Systemic Adverse Events
Number of Patients with Systemic Adverse Events
Time frame: 2 years
Total Number of Other Adverse Events (>5%)
Number of Patients with Other Adverse Events
Time frame: 2 years
| Milestone | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept |
|---|---|---|---|
| Started | 21 | 21 | 21 |
| Completed | 0 | 0 | 1 |
| Not completed | 21 | 21 | 20 |
| Withdrew: The study was discontinued | 21 | 21 | 20 |
Number of Patients with Systemic Adverse Events
| Participants | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept |
|---|---|---|---|
| Total Numer of Systemic Adverse Events | 3 | 3 | 5 |
Number of Patients with Other Adverse Events
| Participants | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept |
|---|---|---|---|
| Total Number of Other Adverse Events (>5%) | 15 | 16 | 16 |
Collected over Up to a maximum exposure of 24 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fovista® Plus Bevacizumab | 0/21 (0%) | 3/21 (14.3%) | 15/21 (71.4%) |
| Fovista® Plus Ranibizumab | 0/21 (0%) | 3/21 (14.3%) | 16/21 (76.2%) |
| Fovista® Plus Aflibercept | 0/21 (0%) | 5/21 (23.8%) | 16/21 (76.2%) |
| Event | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept |
|---|---|---|---|
| Myocardial infarctionCardiac disorders | 0/21 | 0/21 | 1/21 |
| Retinal detachmentEye disorders | 0/21 | 1/21 | 0/21 |
| Retinal haemorrhageEye disorders | 0/21 | 1/21 | 0/21 |
| Non-cardiac chest painGeneral disorders | 0/21 | 0/21 | 1/21 |
| DiverticulitisInfections and infestations | 1/21 | 0/21 | 0/21 |
| Pneumonia staphylococcalInfections and infestations | 1/21 | 0/21 | 0/21 |
| Joint dislocationInjury, poisoning and procedural complications | 0/21 | 1/21 | 0/21 |
| Intraocular pressure increasedInvestigations | 1/21 | 0/21 | 0/21 |
| Cervical spine stenosisMusculoskeletal and connective tissue disorders | 0/21 | 0/21 | 1/21 |
| Lumbar spinal stenosisMusculoskeletal and connective tissue disorders | 0/21 | 0/21 | 1/21 |
| Event | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept |
|---|---|---|---|
| Conjuctival haemorrhageEye disorders | 7/21 | 6/21 | 1/21 |
| Neovascular age-related macular degenerationEye disorders | 4/21 | 1/21 | 6/21 |
| Intraocular pressure increasedInvestigations | 3/21 | 2/21 | 6/21 |
| NasopharyngitisInfections and infestations | 0/21 | 5/21 | 1/21 |
| CataractEye disorders | 1/21 | 3/21 | 4/21 |
| Eye painEye disorders | 4/21 | 0/21 | 4/21 |
| Visual acuity reducedEye disorders | 0/21 | 0/21 | 4/21 |
| Vitreous floatersEye disorders | 1/21 | 2/21 | 3/21 |
| Retinal haemorrhageEye disorders | 1/21 | 3/21 | 1/21 |
| SinusitisInfections and infestations | 0/21 | 1/21 | 3/21 |
| Age, Categorical(Participants) | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 3 | 2 | 8 |
| >=65 years | 18 | 18 | 19 | 55 |
| Age, Continuous(years) | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept | Total |
|---|---|---|---|---|
| Mean | 78.5 ± 9.51 | 77.2 ± 10.43 | 77.9 ± 8.99 | 77.9 ± 9.51 |
| Sex: Female, Male(Participants) | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept | Total |
|---|---|---|---|---|
| Female | 13 | 16 | 15 | 44 |
| Male | 8 | 5 | 6 | 19 |
| Race (NIH/OMB)(Participants) | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 |
| White | 21 | 21 | 20 | 62 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Fovista® Plus Bevacizumab | Fovista® Plus Ranibizumab | Fovista® Plus Aflibercept | Total |
|---|---|---|---|---|
| United States | 21 | 21 | 21 | 63 |
Plan to share: No — 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/.
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