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A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02387957
Enrollment
63
Registered
2015-03-13
Start date
2016-04-26
Completion date
2017-01-31
Last updated
2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Keywords

Wet AMD, subfoveal choroidal neovascularization, Fovista®, Avastin®, Lucentis®, Eylea®

Brief summary

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Detailed description

60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows: * Avastin® 1.25 mg/eye (20 subjects) * Lucentis® 0.5 mg/eye (20 subjects) * Eylea® 2.0 mg/eye (20 subjects) 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).

Interventions

DRUGbevacizumab
DRUGFovista®
DRUGranibizumab
DRUGaflibercept

Sponsors

Ophthotech Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subjects of either gender aged ≥ 50 years. * Active subfoveal choroidal neovascularization (CNV) due to AMD.

Exclusion criteria

* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication. * Subjects with subfoveal scar or subfoveal atrophy * Any ocular or periocular infection in the past twelve (12) weeks. * History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Design outcomes

Primary

MeasureTime frameDescription
Total Numer of Systemic Adverse Events2 yearsNumber of Patients with Systemic Adverse Events
Total Number of Other Adverse Events (>5%)2 yearsNumber of Patients with Other Adverse Events

Countries

United States

Participant flow

Participants by arm

ArmCount
Fovista® Plus Bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection Fovista® bevacizumab
21
Fovista® Plus Ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection Fovista® ranibizumab
21
Fovista® Plus Aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection Fovista® aflibercept
21
Total63

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyThe study was discontinued212120

Baseline characteristics

CharacteristicFovista® Plus RanibizumabFovista® Plus AfliberceptTotalFovista® Plus Bevacizumab
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
18 Participants19 Participants55 Participants18 Participants
Age, Categorical
Between 18 and 65 years
3 Participants2 Participants8 Participants3 Participants
Age, Continuous77.2 years
STANDARD_DEVIATION 10.43
77.9 years
STANDARD_DEVIATION 8.99
77.9 years
STANDARD_DEVIATION 9.51
78.5 years
STANDARD_DEVIATION 9.51
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
21 Participants20 Participants62 Participants21 Participants
Region of Enrollment
United States
21 participants21 participants63 participants21 participants
Sex: Female, Male
Female
16 Participants15 Participants44 Participants13 Participants
Sex: Female, Male
Male
5 Participants6 Participants19 Participants8 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 210 / 21
other
Total, other adverse events
15 / 2116 / 2116 / 21
serious
Total, serious adverse events
3 / 213 / 215 / 21

Outcome results

Primary

Total Number of Other Adverse Events (>5%)

Number of Patients with Other Adverse Events

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Fovista® Plus BevacizumabTotal Number of Other Adverse Events (>5%)15 Participants
Fovista® Plus RanibizumabTotal Number of Other Adverse Events (>5%)16 Participants
Fovista® Plus AfliberceptTotal Number of Other Adverse Events (>5%)16 Participants
Primary

Total Numer of Systemic Adverse Events

Number of Patients with Systemic Adverse Events

Time frame: 2 years

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Fovista® Plus BevacizumabTotal Numer of Systemic Adverse Events3 Participants
Fovista® Plus RanibizumabTotal Numer of Systemic Adverse Events3 Participants
Fovista® Plus AfliberceptTotal Numer of Systemic Adverse Events5 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026