Trial Outcomes & Findings for 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) (NCT NCT02387957)
NCT ID: NCT02387957
Last Updated: 2024-10-30
Results Overview
Number of Patients with Systemic Adverse Events
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
63 participants
Primary outcome timeframe
2 years
Results posted on
2024-10-30
Participant Flow
Participant milestones
| Measure |
Fovista® Plus Bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
20
|
Reasons for withdrawal
| Measure |
Fovista® Plus Bevacizumab
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
|---|---|---|---|
|
Overall Study
The study was discontinued
|
21
|
21
|
20
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Fovista® Plus Bevacizumab
n=21 Participants
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
n=21 Participants
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
n=21 Participants
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
|
Age, Continuous
|
78.5 years
STANDARD_DEVIATION 9.51 • n=5 Participants
|
77.2 years
STANDARD_DEVIATION 10.43 • n=7 Participants
|
77.9 years
STANDARD_DEVIATION 8.99 • n=5 Participants
|
77.9 years
STANDARD_DEVIATION 9.51 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 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
|
1 Participants
n=5 Participants
|
1 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
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
62 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
|
21 participants
n=5 Participants
|
21 participants
n=7 Participants
|
21 participants
n=5 Participants
|
63 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of Patients with Systemic Adverse Events
Outcome measures
| Measure |
Fovista® Plus Bevacizumab
n=21 Participants
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
n=21 Participants
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
n=21 Participants
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
|---|---|---|---|
|
Total Numer of Systemic Adverse Events
|
3 Participants
|
3 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of Patients with Other Adverse Events
Outcome measures
| Measure |
Fovista® Plus Bevacizumab
n=21 Participants
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
n=21 Participants
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
n=21 Participants
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
|---|---|---|---|
|
Total Number of Other Adverse Events (>5%)
|
15 Participants
|
16 Participants
|
16 Participants
|
Adverse Events
Fovista® Plus Bevacizumab
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Fovista® Plus Ranibizumab
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Fovista® Plus Aflibercept
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fovista® Plus Bevacizumab
n=21 participants at risk
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
n=21 participants at risk
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
n=21 participants at risk
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Retinal detachment
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Diverticulitis
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Pneumonia staphylococcal
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Investigations
Intraocular pressure increased
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Musculoskeletal and connective tissue disorders
Cervical spine stenosis
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified reccurent
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
Other adverse events
| Measure |
Fovista® Plus Bevacizumab
n=21 participants at risk
Fovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Fovista®
bevacizumab
|
Fovista® Plus Ranibizumab
n=21 participants at risk
Fovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Fovista®
ranibizumab
|
Fovista® Plus Aflibercept
n=21 participants at risk
Fovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Fovista®
aflibercept
|
|---|---|---|---|
|
Eye disorders
Neovascular age-related macular degeneration
|
19.0%
4/21 • Number of events 4 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
28.6%
6/21 • Number of events 6 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Cataract
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
14.3%
3/21 • Number of events 6 • Up to a maximum exposure of 24 months
|
19.0%
4/21 • Number of events 4 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Eye pain
|
19.0%
4/21 • Number of events 4 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
19.0%
4/21 • Number of events 6 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
19.0%
4/21 • Number of events 5 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Vitreous floaters
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
14.3%
3/21 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Conjuctival haemorrhage
|
33.3%
7/21 • Number of events 11 • Up to a maximum exposure of 24 months
|
28.6%
6/21 • Number of events 16 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Eye irritation
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Retinal haemorrhage
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
14.3%
3/21 • Number of events 3 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Vitreous detachment
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
General disorders
Seasonal allergy
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
14.3%
3/21 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
23.8%
5/21 • Number of events 5 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
|
Investigations
Intraocular pressure increased
|
14.3%
3/21 • Number of events 6 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 4 • Up to a maximum exposure of 24 months
|
28.6%
6/21 • Number of events 9 • Up to a maximum exposure of 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
4.8%
1/21 • Number of events 1 • Up to a maximum exposure of 24 months
|
9.5%
2/21 • Number of events 2 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Ocular Discomfort
|
9.5%
2/21 • Number of events 3 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
0.00%
0/21 • Up to a maximum exposure of 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution agrees not to individually publish the results of the Study without Ophthotech's prior written consent. Institution may participate in a joint, multi-center publication of the Study results with other investigators and/or institutions only, upon the prior written consent of Ophthotech.
- Publication restrictions are in place
Restriction type: OTHER