Trial Outcomes & Findings for Study to Assess Best Corrected Visual Acuity (BCVA) in Patients With Neovascular Age-Related Macular Degeneration (AMD) Who Are Administered VEGF Trap-Eye (Intravitreal Aflibercept Injection) (NCT NCT01722045)
NCT ID: NCT01722045
Last Updated: 2017-12-22
Results Overview
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
Baseline to Week 100
Results posted on
2017-12-22
Participant Flow
The study was conducted at 43 sites in the US from 14Nov2012 to 03Sep2015. The target study population consisted of men and women 50 years of age and older with neovascular AMD who met all study eligibility criteria. A total of 288 patients were screened, of whom 154 patients were enrolled and treated. A total of 126 patients completed week 100.
Participant milestones
| Measure |
Open Label IAI
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
COMPLETED
|
126
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Open Label IAI
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Protocol Deviation
|
1
|
|
Overall Study
Physician Decision
|
3
|
|
Overall Study
Relocation (did not wish to transfer)
|
1
|
Baseline Characteristics
EES
Baseline characteristics by cohort
| Measure |
Open Label IAI
n=154 Participants
Intravitreal Aflibercept Injection (IAI)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=154 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=154 Participants
|
|
Age, Categorical
>=65 years
|
137 Participants
n=154 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=154 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=154 Participants
|
|
Best Corrected Visual Acuity (BCVA) in the study eye (Letters Read)
|
54.3 letters correctly read
STANDARD_DEVIATION 13.47 • n=154 Participants
|
|
Central Subfield Thickness in the study eye by Optical Coherence Tomography (OCT)
|
420.5 micrometers (μm)
STANDARD_DEVIATION 134.90 • n=154 Participants
|
|
Corneal Endothelial Cell Density - Endothelial Cell Density Evaluable Set (EES)
Study eye
|
2409.8 cells/mm^2
STANDARD_DEVIATION 363.89 • n=118 Participants • EES
|
|
Corneal Endothelial Cell Density - Endothelial Cell Density Evaluable Set (EES)
Fellow eye
|
2388.0 cells/mm^2
STANDARD_DEVIATION 383.93 • n=118 Participants • EES
|
PRIMARY outcome
Timeframe: Baseline to Week 100Population: Results are presented for the full analysis set (FAS). FAS included all patients who received at least one dose of study drug in the study eye, had baseline Best Corrected Visual Acuity (BCVA) assessment on the study eye, and had at least one post-baseline BCVA assessment on the study eye.
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.
Outcome measures
| Measure |
Open Label IAI
n=151 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)
Week 100
|
58.7 letters correctly read
Standard Deviation 20.5
|
|
Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score From Baseline to Week 100 - Last Observation Carried Forward (LOCF)
Change from Baseline at Week 100
|
4.5 letters correctly read
Standard Deviation 17.2
|
SECONDARY outcome
Timeframe: Baseline to Week 100Population: Full analysis set (FAS)
Retinal fluid status was evaluated using spectral domain OCT on the study eye at every study visit. Last observation carried forward (LOCF) method was used to impute missing data.
Outcome measures
| Measure |
Open Label IAI
n=151 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
Baseline: Dry
|
0.7 percentage of participants
|
|
Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
Baseline: Not Dry
|
99.3 percentage of participants
|
|
Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
Week 52: Dry
|
53.0 percentage of participants
|
|
Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
Week 52: Not Dry
|
47.0 percentage of participants
|
|
Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
Week 100: Dry
|
51.7 percentage of participants
|
|
Percentage of Participants Whose Optical Coherence Tomography (OCT) Status Was "Dry" at Week 52 and at Week 100 (LOCF)
Week 100: Not Dry
|
48.3 percentage of participants
|
SECONDARY outcome
Timeframe: At week 52 and At week 100Population: FAS
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. LOCF approach was used if any ETDRS letter score was missed after start of treatment, but baseline data were not carried forward. No formal statistical analyses were performed.
Outcome measures
| Measure |
Open Label IAI
n=151 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)
At week 52
|
25.8 percentage of participants
|
|
Percentage of Participants Who Gained ≥15 ETDRS Letters Compared With Baseline at Week 52 and Week 100 (LOCF)
At week 100
|
22.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 52Population: FAS
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision.
Outcome measures
| Measure |
Open Label IAI
n=151 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)
At Week 52
|
60.1 Letters correctly read
Standard Deviation 18.94
|
|
Change From Baseline in Best Corrected Visual Acuity Score Through Week 52 (LOCF)
Change from Baseline at Week 52
|
5.9 Letters correctly read
Standard Deviation 15.54
|
SECONDARY outcome
Timeframe: Baseline to Week 100Population: FAS
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Outcome measures
| Measure |
Open Label IAI
n=151 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)
Gained ≥ 0 Letters at Week 100
|
70.9 percentage of participants
|
|
Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)
Gained ≥ 5 Letters at Week 100
|
57.6 percentage of participants
|
|
Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)
Gained ≥10 Letters at Week 100
|
40.4 percentage of participants
|
|
Percentage of Participants Who Gained ≥0, ≥5, ≥10, or ≥30 Letters From Baseline in BCVA Through Week 100 (LOCF)
Gained ≥30 Letters at Week 100
|
4.6 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 100Population: FAS
Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better functioning.
Outcome measures
| Measure |
Open Label IAI
n=151 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)
Lost >0 Letters at Week 100
|
29.1 percentage of participants
|
|
Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)
Lost ≥5 Letters at Week 100
|
23.2 percentage of participants
|
|
Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)
Lost ≥10 Letters at Week 100
|
16.6 percentage of participants
|
|
Percentage of Patients Who Lost >0, ≥5, ≥10, or ≥15 Letters From Baseline in BCVA Through Week 100 (LOCF)
Lost ≥15 Letters at Week 100
|
13.2 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At week 24 and At week 52Population: EES
EES included all eligible patients who were treated in the study eye, untreated in the fellow eye, had baseline specular microscopy image in both eyes, and completed week 52 evaluation in both eyes and treatment with systemic anti-VEGF therapeutics
Outcome measures
| Measure |
Open Label IAI
n=118 Participants
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)
Week 24: Study eye
|
-0.3 percent change from baseline
Standard Deviation 4.15
|
|
Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)
Week 24: Fellow eye
|
1.0 percent change from baseline
Standard Deviation 4.28
|
|
Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)
Week 52: Study eye
|
-0.2 percent change from baseline
Standard Deviation 4.19
|
|
Percent Change From Baseline in Corneal Endothelial Cell Density (ECD) at Week 24 and Week 52 in the Study Eye and the Fellow Eye - Endothelial Cell Density Evaluable Set (EES)
Week 52: Fellow eye
|
-0.3 percent change from baseline
Standard Deviation 4.04
|
Adverse Events
Open Label IAI
Serious events: 45 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label IAI
n=154 participants at risk
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Blood and lymphatic system disorders
Autoimmune haemolytic anaemia
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma metastatic
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer metastatic
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
1.9%
3/154 • Adverse event data were collected during the period baseline to week 100
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma metastatic
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Vascular disorders
Hypotension
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Vascular disorders
Orthostatic hypotension
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Vascular disorders
Thromboangiitis obliterans
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Ear and labyrinth disorders
Vertigo
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Cataract
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Detachment of retinal pigment epithelium
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Retinal haemorrhage
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Retinal pigment epithelial tear
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Abdominal pain
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Diarrhoea
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Diverticulum
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Diverticulum intestinal haemorrhagic
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
General disorders
Fatigue
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
2/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Angina unstable
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Arrhythmia
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
3/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Bradycardia
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Cardiac arrest
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Cardiac failure congestive
|
2.6%
4/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Coronary artery disease
|
1.9%
3/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Coronary artery occlusion
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
2/154 • Adverse event data were collected during the period baseline to week 100
|
|
Cardiac disorders
Ventricular tachycardia
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Appendicitis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Cellulitis
|
1.3%
2/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Endophthalmitis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Perirectal abscess
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Peritonitis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Pneumonia
|
1.9%
3/154 • Adverse event data were collected during the period baseline to week 100
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Renal and urinary disorders
Haematuria
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Renal and urinary disorders
Hydronephrosis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Renal and urinary disorders
Renal failure
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Carotid artery stenosis
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Cerebral infarction
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Dizziness
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Dysarthria
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Embolic stroke
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Lacunar infarction
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Syncope
|
1.3%
2/154 • Adverse event data were collected during the period baseline to week 100
|
|
Nervous system disorders
Transient ischaemic attack
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Psychiatric disorders
Mental status changes
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.65%
1/154 • Adverse event data were collected during the period baseline to week 100
|
Other adverse events
| Measure |
Open Label IAI
n=154 participants at risk
2 mg IAI (Intravitreal Aflibercept Injection) at 4-week intervals (2Q4) up to week 8 for a total of 3 injections, and 2 mg at 8-week intervals (2Q8) thereafter until week 96
|
|---|---|
|
Vascular disorders
Hypertension
|
8.4%
13/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Conjunctival haemorrhage
|
7.8%
12/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Neovascular age-related macular degeneration
|
13.0%
20/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Vitreous detachment
|
5.8%
9/154 • Adverse event data were collected during the period baseline to week 100
|
|
Eye disorders
Vitreous floaters
|
5.8%
9/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Bronchitis
|
6.5%
10/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Nasopharyngitis
|
5.8%
9/154 • Adverse event data were collected during the period baseline to week 100
|
|
Infections and infestations
Urinary tract infection
|
7.8%
12/154 • Adverse event data were collected during the period baseline to week 100
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After completion of the trial, the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review; provided that the sponsor can remove confidential or proprietary information from such communications. The sponsor cannot require other changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER