A Phase 3 interventional study of E10030 and bevacizumab or aflibercept in Age-Related Macular Degeneration, sponsored by Ophthotech Corporation. Terminated at 207 sites in 22 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-10-31.
Sponsored by Ophthotech Corporation (part of Astellas Pharma Inc) · Phase 3, Interventional, and Treatment
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Subjects will be randomized in a 1:1 ratio to the following two arms per study design:
Subjects will be treated for up to 24 months with active Fovista® or sham, in combination with either Avastin® or Eylea® with the primary endpoint at 12 months.
Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP
1,490 studies on the registry are indexed under Macular Degeneration; 208 are open to participants now.
This study's enrollment of 645 is above the median of 50 across 993 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Ophthotech Corporation is the lead sponsor of 13 studies on the registry; none are open to participants now.
First submitted before Ophthotech Corporation became part of Astellas Pharma Inc.
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Exclusion Criteria:
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Drug: E10030 · Drug: bevacizumab or aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Drug: bevacizumab or aflibercept · Drug: E10030 sham injection
Also known as: Fovista®
Patients are randomized to receive either bevacizumab or aflibercept
Also known as: Avastin®, Eylea®
Pressure on the eye with a syringe with no needle
Also known as: Sham
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
Time frame: 12 months
The study was conducted at 214 centers (107 in North America and 107 in the rest of the world) in 22 countries (20 of which enrolled patients) between 19 May 2014 and 15 September 2017.
| Milestone | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept |
|---|---|---|
| Started | 322 | 320 |
| Completed | 283 | 297 |
| Not completed | 39 | 23 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Physician decision | 7 | 3 |
| Withdrew: Death | 5 | 3 |
| Withdrew: Adverse event | 7 | 6 |
| Withdrew: Withdrawal by subject | 18 | 9 |
| Withdrew: Lost to follow-up | 2 | 1 |
| Milestone | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept |
|---|---|---|
| Started | 283 | 297 |
| Completed | 66 | 75 |
| Not completed | 217 | 222 |
| Withdrew: Physician decision | 8 | 1 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Sponsor decision, early termination | 192 | 203 |
| Withdrew: Adverse event | 8 | 2 |
| Withdrew: Withdrawal by subject | 8 | 8 |
| Withdrew: Lost to follow-up | 1 | 6 |
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
| letters | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept |
|---|---|---|
| Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit) | 9.42 ± 0.85 | 9.04 ± 0.85 |
Collected over All-Cause Mortality data was collected for up to 2 years, and Adverse events (AEs) were collected for up to 12 months of exposure (Year 1) for the 2 pre-specified treatment groups (E10030 + Bevacizumab or Aflibercept vs. Sham + Bevacizumab or Aflibercept), per the study design and the SAP.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| E10030 + Bevacizumab or Aflibercept | 7/322 (2.2%) | 58/322 (18%) | 105/322 (32.6%) |
| Sham + Bevacizumab or Aflibercept | 6/320 (1.9%) | 32/320 (10%) | 107/320 (33.4%) |
| Event | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept |
|---|---|---|
| PneumoniaInfections and infestations | 5/322 | 2/320 |
| EndophthalmitisInfections and infestations | 4/322 | 1/320 |
| Atrial fibrillationCardiac disorders | 2/322 | 3/320 |
| Cardiac failure congestiveCardiac disorders | 2/322 | 3/320 |
| AnaemiaBlood and lymphatic system disorders | 3/322 | 0/320 |
| Hip fractureInjury, poisoning and procedural complications | 3/322 | 0/320 |
| Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 3/322 | 0/320 |
| Pancreatitis acuteGastrointestinal disorders | 0/322 | 2/320 |
| BronchitisInfections and infestations | 1/322 | 2/320 |
| Retinal haemorrhageEye disorders | 2/322 | 0/320 |
| Event | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept |
|---|---|---|
| Conjunctival haemorrhageEye disorders | 39/322 | 31/320 |
| Intraocular pressure increasedInvestigations | 22/322 | 20/320 |
| Eye painEye disorders | 18/322 | 21/320 |
| Punctate keratitisEye disorders | 21/322 | 14/320 |
| Vitreous detachmentEye disorders | 20/322 | 19/320 |
| Neovascular age-related macular degenerationEye disorders | 16/322 | 19/320 |
| NasopharyngitisInfections and infestations | 14/322 | 17/320 |
| Age, Continuous(years) | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept | Total |
|---|---|---|---|
| Mean | 76.5 ± 8.36 | 76.6 ± 8.36 | 76.6 ± 8.36 |
| Age, Customized(Participants) | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept | Total |
|---|---|---|---|
| Age — Adults 18-64 years | 31 | 25 | 56 |
| Age — Adults 65-84 years | 239 | 239 | 478 |
| Age — Adults 85 years and over | 52 | 56 | 108 |
| Sex: Female, Male(Participants) | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept | Total |
|---|---|---|---|
| Female | 178 | 192 | 370 |
| Male | 144 | 128 | 272 |
| Ethnicity (NIH/OMB)(Participants) | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept | Total |
|---|---|---|---|
| Hispanic or Latino | 28 | 23 | 51 |
| Not Hispanic or Latino | 294 | 297 | 591 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | E10030 + Bevacizumab or Aflibercept | Sham + Bevacizumab or Aflibercept | Total |
|---|---|---|---|
| Colombia | 7 | 5 | 12 |
| Argentina | 4 | 4 | 8 |
| Hungary | 48 | 50 | 98 |
| United States | 92 | 95 | 187 |
| Czechia | 15 | 14 | 29 |
| Portugal | 9 | 12 | 21 |
| Spain | 10 | 10 | 20 |
| Canada | 1 | 1 | 2 |
| Austria | 2 | 3 | 5 |
| Latvia | 8 | 7 | 15 |
| Poland | 1 | 3 | 4 |
| Brazil | 3 | 3 | 6 |
| Italy | 28 | 29 | 57 |
| Israel | 32 | 28 | 60 |
| Slovakia | 1 | 0 | 1 |
| Australia | 2 | 3 | 5 |
| France | 26 | 23 | 49 |
| Croatia | 22 | 21 | 43 |
| Estonia | 9 | 7 | 16 |
Showing the first 100 of 207 sites across 22 countries.
Documents are hosted by the registry — open the source record to download them.
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/.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pegpleranib sodium