Trial Outcomes & Findings for An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy (NCT NCT03117634)

Last Updated: 2021-08-18

Results Overview

Mean Change in Best corrected visual acuity (BCVA) from baseline to week 52 for personalized and fixed regimen. it is a Non-inferiority of personalized to fixed regimen for mean change in BCVA from baseline to week 52 (Non-inferiority is considered as -5 ETDRS Letters difference )

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

54 participants

Primary outcome timeframe

From Baseline to Week 52

Results posted on

2021-08-18

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Personalised Group The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Overall Study STARTED	41 41	13 13
Overall Study COMPLETED	39 39	13 13
Overall Study NOT COMPLETED	2 2	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open Label-study to Compare the Efficacy of Aflibercept Monotherapy for Polypoidal Choroidal Vasculopathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Personalised Group n=39 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 Participants All Study participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.	Total n=52 Participants Total of all reporting groups
Age, Continuous	69.2 years STANDARD_DEVIATION 9.3 • n=5 Participants	69.3 years STANDARD_DEVIATION 6.6 • n=7 Participants	69.25 years STANDARD_DEVIATION 8.6 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	5 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	8 Participants n=7 Participants	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	39 Participants n=5 Participants	13 Participants n=7 Participants	52 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Singapore	39 participants n=5 Participants	13 participants n=7 Participants	52 participants n=5 Participants
Best Corrected Visual Acuity(BCVA)	58 ETDRS Letters (units on a scale) STANDARD_DEVIATION 14.2 • n=5 Participants	62.8 ETDRS Letters (units on a scale) STANDARD_DEVIATION 12.6 • n=7 Participants	60.4 ETDRS Letters (units on a scale) STANDARD_DEVIATION 14.3 • n=5 Participants
Central sub field thickness (CSFT)	446.5 microns STANDARD_DEVIATION 181.6 • n=5 Participants	483.2 microns STANDARD_DEVIATION 189.3 • n=7 Participants	464.85 microns STANDARD_DEVIATION 183.5 • n=5 Participants

PRIMARY outcome

Timeframe: From Baseline to Week 52

Population: Mean Change in Best corrected visual acuity (BCVA) from baseline to week 52 for personalized and fixed regimen. it is a Non-inferiority of personalized to fixed regimen for mean change in BCVA from baseline to week 52

Outcome measures

Outcome measures
Measure	Personalised Group n=39 Eyes The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 Eyes The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Mean Change in Best Corrected Visual Acuity (BCVA)	8.1 ETDRS Letters Interval 6.5 to 10.6	7.9 ETDRS Letters Interval 5.2 to 10.4

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: change in the central sub field thickness (CSFT) assessed by OCT from baseline to week 52 between personalised and fixed group

central sub field thickness (CSFT) was defined as the average thickness of the macula in the central 1 mm ETDRS grid. Defined as the thickness from the inner retinal boundary at the location of the inner limiting membrane (ILM) to the outer retinal boundary at Bruch's membrane (BM). Change in the central sub field thickness (CSFT) after the treatment was assessed , the measurement was done by optical coherence tomography (OCT). the measures were taken at baseline and week 52, the change between the two measurements ( baseline to week 52) were assessed in both groups to understand the effect of treatment on CSFT

Outcome measures

Outcome measures
Measure	Personalised Group n=39 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Mean Change in Central Sub Field Thickness	-248.8 um Standard Deviation 169.9	-164.8 um Standard Deviation 148.9

SECONDARY outcome

Timeframe: At Week 52

Population: number of participants with complete polypoidal lesion closure as detected on Indocyanine green angiography (ICGA) as no leakage on late ICGA stage between personalised and fixed groups

This measure reports the Number of participants with complete polypoidal lesion closure defined as those showing no late leakage on Indocyanine green angiography (ICGA).

Outcome measures

Outcome measures
Measure	Personalised Group n=39 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Number of Participants With Complete Polypoidal Lesion Closure	21 Participants	5 Participants

SECONDARY outcome

Timeframe: From Baseline to Week 52

Population: number of aflibercept injections administered in the induction phase in both groups

number of aflibercept injections administered in personalised and fixed groups

Outcome measures

Outcome measures
Measure	Personalised Group n=40 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 Participants The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Number of Injections	8.2 Injections Standard Deviation 0.9	8 Injections Standard Deviation 0

Adverse Events

Personalised Group

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

Fixed Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Personalised Group n=39 participants at risk The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 participants at risk The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Gastrointestinal disorders Cancer	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Gastrointestinal disorders Ulcer	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Social circumstances Fall	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.

Other adverse events

Other adverse events
Measure	Personalised Group n=39 participants at risk The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, the participants had repeat ICGA and OCT. At week 12, participants in this group, in whom, polypoidal lesions had completely regressed on ICGA would enter into the treat and extend (TNE)phase. Participants with presence of polypoidal lesions (PL) on ICGA (with or without fluid on OCT) would continue three 4-weekly injections till week 24, and enter TNE phase from week 24 onwards.	Fixed Group n=13 participants at risk The participants received an induction phase of treatment defined as 4 weekly intravitreal aflibercept 2mg/0.05ml at week 0, week 4 and week 8. At week 12, all participants had repeat ICGA and OCT. Participants in the fixed group went on to receive fix doses of 8-weekly aflibercept 2mn/0.05ml after the induction phase for the remaining duration of the study.
Eye disorders Drop in Visual Acuity	5.1% 2/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	7.7% 1/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Eye disorders Stye (Extra-Ocular)	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Eye disorders Punctate epithelial erosion	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	7.7% 1/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Eye disorders Peri-orbital Oedema (Extra-Ocular)	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Eye disorders Drop in vision due to cataract	5.1% 2/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Eye disorders riased intraocular pressure	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	7.7% 1/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
General disorders Raised blood pressure	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	7.7% 1/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.
Eye disorders Rapid Active Disease Progression	2.6% 1/39 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.	0.00% 0/13 • The Adverse events (AE) and serious Adverse events (SAE) were recorded on or after the date of the administration of first study treatment, for an average of 1 year. Adverse events : Any Hospitalisation for routine treatment or monitoring of the studied indication not associated with any deterioration in condition, hospitalisation for elective or preplanned treatment for a pre-existing condition that is unrelated to the indication under study and has not worsened since the start of the study and treatment on an emergency outpatient basis for an event not fulfilling the definitions of a SAE given above and not resulting in hospital admission.

Additional Information

Gemmy Cheung, Principal Investigator

Singapore National Eye Center

Phone: +65 6322 8335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contract Partners shall provide to Sponsor any proposed publication or oral presentation relating to the Study or Study Drug and Results (Publications), at least thirty days prior to the intended submission or presentation in order to allow SPONSOR to review it. If Sponsor does not notify Contract Partner within thirty (30) days of receipt of intended Publication, Contract Partner shall be free to publish.
Publication restrictions are in place

Restriction type: OTHER