Trial Outcomes & Findings for Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD (NCT NCT02214628)
NCT ID: NCT02214628
Last Updated: 2024-02-23
Results Overview
Number of subjects on either arm with non-serious adverse events (reported by \>5% of subjects)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
2 years
Results posted on
2024-02-23
Participant Flow
Participant milestones
| Measure |
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
|
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration
|
|---|---|---|
|
Overall Study
STARTED
|
63
|
38
|
|
Overall Study
COMPLETED
|
36
|
9
|
|
Overall Study
NOT COMPLETED
|
27
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD
Baseline characteristics by cohort
| Measure |
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous
n=63 Participants
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration
|
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
n=38 Participants
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration
|
Total
n=101 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
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
60 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
Age, Continuous
|
78.3 years
STANDARD_DEVIATION 7.92 • n=5 Participants
|
74.8 years
STANDARD_DEVIATION 9.89 • n=7 Participants
|
77.0 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
63 participants
n=5 Participants
|
38 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of subjects on either arm with non-serious adverse events (reported by \>5% of subjects)
Outcome measures
| Measure |
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen
n=63 Participants
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
|
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
n=38 Participants
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
|
|---|---|---|
|
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
|
51 Participants
|
34 Participants
|
PRIMARY outcome
Timeframe: 2 yearsNumber of subjects with serious adverse events in each arm
Outcome measures
| Measure |
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen
n=63 Participants
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
|
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
n=38 Participants
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events
|
19 Participants
|
8 Participants
|
Adverse Events
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen
Serious events: 19 serious events
Other events: 51 other events
Deaths: 2 deaths
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
Serious events: 8 serious events
Other events: 34 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen
n=63 participants at risk
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
|
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
n=38 participants at risk
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
|
|---|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Cardiac disorders
Supraventricular tachycardia
|
1.6%
1/63 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Endocrine disorders
Hyperparathyroidism
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Retinal detachment
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
General disorders
Surgical failure
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Hepatobiliary disorders
Biloma
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Immune system disorders
Anaphylactic reaction
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Immune system disorders
Drug hypersensitivity
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Appendiceal abscess
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Appendicitis perforated
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Cellulitis
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Endophthalmitis
|
3.2%
2/63 • Number of events 2 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Pneumonia
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Postoperative wound infection
|
3.2%
2/63 • Number of events 2 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Facial bone fracture
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
3/63 • Number of events 5 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Hip fracture
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Laceration
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Perirenal haematoma
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Investigations
Blood pressure decreased
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis to lung
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Nervous system disorders
Dizziness
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Nervous system disorders
Ischemic stroke
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.6%
1/63 • Number of events 3 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
|
Vascular disorders
Shock haemorrhagic
|
1.6%
1/63 • Number of events 1 • Up to a maximum exposure of 24 months
|
0.00%
0/38 • Up to a maximum exposure of 24 months
|
Other adverse events
| Measure |
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Simultaneous Regimen
n=63 participants at risk
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration.
|
Fovista® (Anti-PDGF BB) Plus Anti-VEGF Pre-Treatment Regimen
n=38 participants at risk
Subjects administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
12.7%
8/63 • Number of events 10 • Up to a maximum exposure of 24 months
|
10.5%
4/38 • Number of events 4 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Sinusitis
|
11.1%
7/63 • Number of events 7 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Infections and infestations
Urinary tract infection
|
9.5%
6/63 • Number of events 7 • Up to a maximum exposure of 24 months
|
7.9%
3/38 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Cataract
|
9.5%
6/63 • Number of events 9 • Up to a maximum exposure of 24 months
|
5.3%
2/38 • Number of events 6 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Conjuctival haemorrhage
|
49.2%
31/63 • Number of events 87 • Up to a maximum exposure of 24 months
|
52.6%
20/38 • Number of events 42 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Eye Pain
|
14.3%
9/63 • Number of events 11 • Up to a maximum exposure of 24 months
|
7.9%
3/38 • Number of events 6 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Intraocular pressure increased
|
14.3%
9/63 • Number of events 12 • Up to a maximum exposure of 24 months
|
23.7%
9/38 • Number of events 26 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Neovascular age-related macular degeneration
|
20.6%
13/63 • Number of events 13 • Up to a maximum exposure of 24 months
|
7.9%
3/38 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Retinal haemorrhage
|
7.9%
5/63 • Number of events 10 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Visual acuity reduced
|
3.2%
2/63 • Number of events 2 • Up to a maximum exposure of 24 months
|
7.9%
3/38 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Vitreous detachment
|
11.1%
7/63 • Number of events 7 • Up to a maximum exposure of 24 months
|
2.6%
1/38 • Number of events 1 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Vitreous floaters
|
6.3%
4/63 • Number of events 6 • Up to a maximum exposure of 24 months
|
7.9%
3/38 • Number of events 3 • Up to a maximum exposure of 24 months
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/63 • Up to a maximum exposure of 24 months
|
7.9%
3/38 • Number of events 3 • 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