AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)Phase 4NCT01495221

To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD

A Phase 4 study testing Alfilbercept in people with AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy), run by Vitreous -Retina- Macula Consultants of New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
What is being tested?: Alfilbercept
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Mar 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 50 years
Choroidal neovascularization secondary to AMD
Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS chart
Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT following at least four anti-VEGF treatments within six months before enrollment and a maximum of 5 years of years of treatment for neovascular AMD
Documentation of presence of subretinal fluid and/or cystoid macular edema less than 30 days since last treatment

Who cannot join

Pregnancy (positive pregnancy test) or lactation
Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
Participation in another simultaneous medical investigation or trial
Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.
Presence of significant subfoveal fibrosis or atrophy.

Show all 20Show fewer

Prior treatment with intravitreal aflibercept injection
Prior treatment with triamcinolone in the study eye within 6 months of BSL.
Prior treatment with dexamethasone in the study eye within 30 days prior to BSL
Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL
History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
Active intraocular inflammation (grade trace or above) in the study eye
Current vitreous hemorrhage in the study eye
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Ocular or periocular infection
Active severe intraocular inflammation
Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication)
History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
History of allergy to fluorescein, ICG or iodine, not amenable to treatment
Known hypersensitivity to aflibercept or to any of the excipients

Trial locations and contacts

1 site in 1 country.

United States1 site

Vitreous Retina Macula Consultants of New York
New York, New York, 10022

Other trials in United States

About this study

Conditions: AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
Being tested: Alfilbercept

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AlfilberceptDrug
All patients will receive 2.0 mg intravitreal aflibercept injection.

Study groups in NCT01495221
Study group	Role	What they receive
Intravitreal aflibercept	Other	All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion. Receives: Drug: Alfilbercept

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of Patients With no Fluid on OCT at Week 24
No primary outcome data can be found or provided.
Measured: 24 week
Mean Change in Visual Acuity From Baseline to Week 16
Visual acuity was documented via BCVA at every study visit.
Measured: Baseline to Week 16

Secondary outcomes (2)

Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16
OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Measured: Baseline and week 16
Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16
OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Measured: Baseline and 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Mar 2013

First posted19 Dec 2011 (estimated)
Study startDec 2011
Primary completionMar 2013
Study completionMar 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01495221
Sponsor's protocol ID: HOLD STUDY
Status last verified: Aug 2018
First submitted: 15 Dec 2011
Last updated: 7 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD
ClinicalTrials.gov ID: NCT01495221
Acronym / sponsor ID: HOLD STUDY
Conditions: AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: Vitreous -Retina- Macula Consultants of New YorkUniversity, hospital or other
Study start: Dec 2011
Primary completion: Mar 2013 (actual)
Study completion: Mar 2013 (actual)
First posted: 19 Dec 2011 (estimated)
Results: Posted 7 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intravitreal aflibercept	Other	Drug: AlfilberceptAll eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 50 years
Choroidal neovascularization secondary to AMD
Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS chart
Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT following at least four anti-VEGF treatments within six months before enrollment and a maximum of 5 years of years of treatment for neovascular AMD

Key exclusion criteria (20 listed)

Pregnancy (positive pregnancy test) or lactation
Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
Participation in another simultaneous medical investigation or trial
Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL
Prior treatment with PDT within the past 3 months or more than 4 prior PDT treatments.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AlfilberceptAll patients will receive 2.0 mg intravitreal aflibercept injection.	Drug	Intravitreal aflibercept

Primary outcome

Proportion of Patients With no Fluid on OCT at Week 24
Time frame: 24 week
No primary outcome data can be found or provided.
Mean Change in Visual Acuity From Baseline to Week 16
Time frame: Baseline to Week 16
Visual acuity was documented via BCVA at every study visit.

2 secondary outcomes

Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16
Time frame: Baseline and week 16
Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16
Time frame: Baseline and 16 weeks

Results and safety

Results posted to the registry on 7 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intravitreal Aflibercept	9	9

Primary outcome: Proportion of Patients With no Fluid on OCT at Week 24

Time frame: 24 week

Population analysed: Patients analyzed is zero due to no outcome data was collected at week 24 due to early termination of the clinical study.

Primary outcome: Mean Change in Visual Acuity From Baseline to Week 16

Time frame: Baseline to Week 16. Mean (Standard Deviation). Unit: letters

Measure	Intravitreal Aflibercept n = 9
Value	4.2 (6.3)

Population analysed: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intravitreal Aflibercept	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patients With no Fluid on OCT at Week 24 (time frame: 24 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01495221.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.