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Age Related Macular DegenerationPhase 4NCT01657669

Short-term Clinical Effects of Intravitreal Aflibercept Injection 2.0mg as a Predictor of Long-term Results

A Phase 4 study testing Intravitreal Aflibercept injection in people with Age Related Macular Degeneration, run by Retina Research Institute, LLC at 3 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD). Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Age Related Macular Degeneration
What is being tested?
Intravitreal Aflibercept injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
3 sitesUnited States
Study dates
Oct 2012to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • 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 and above.
  • Choroidal neovascularization secondary to AMD with central retinal thickness greater than or equal to 300um.
  • Best corrected visual acuity in the study eye between 20/40 and 20/400 using an ETDRS chart -

Who cannot join

  • Pregnancy (positive urine 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 a study or an investigational drug or device within the past 30 days prior to enrolling in the study.
  • Presence of significant subfoveal fibrosis or atrophy.
  • Previously treated subjects:
  • Prior treatment with anti-VEGF therapy in the study eye within 28 days of baseline More than six (6) prior treatments with anti-VEGF therapy in the study eye within 1 year.
Show all 20Show fewer
  • Prior treatment with PDT within the past 3 months or more than 2 prior PDT treatments.
  • Prior treatment with intravitreal aflibercept injection Prior treatment with triamcinolone in the study eye within 6 months of baseline.
  • Prior treatment with dexamethasone in the study eye within 30 days prior to baseline.
  • Intraocular surgery (including cataract surgery)in the study eye within 2 months preceding baseline
  • 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.
  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
  • Uncontrolled glaucoma in the study eye (defined as IOP greater than or equal to 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
  • History of retinal pigment epithelial tear or rip.
  • -

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Valley Retina Institute

    McAllen, Texas, 78503

  • The Retina Institute

    St Louis, Missouri, 63128

  • The Retina Institute

    St Louis, Missouri, 63141

Other trials in United States

About this study

This is an open label study to evaluate 2.0 mg intravitreal aflibercept injection administered in subject who have active choroidal neovascularization due to Age Related Macular Degeneration (AMD).

Read the detailed description

Twenty (20) consented participant who meet the inclusion criteria will be enrolled to be followed for 48 weeks. All subjects will receive 2.0 mg intravitreal aflibercept injections with three initial monthly doses, and mandatory doses at Weeks 16, 24, 32, and 40. Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on Optical Coherence Tomography (OCT) and/or a decrease in visual acuity of greater than or equal to 5 letters from the best previous visit. Only one eye will be enrolled in the study.

Being tested
Intravitreal Aflibercept injection
Keywords
Choroidal neovascularization due to AMD
Medical subject headings
Macular Degeneration

What participants receive

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

  • Intravitreal Aflibercept injectionDrug

    Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.

Study groups in NCT01657669
Study groupRoleWhat they receive
Intravitreal Aflibercept injectionOtherIntravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mg) via intravitreal injection once every 8 weeks (2 months).
Receives: Drug: Intravitreal Aflibercept injection

What is being measured

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

  1. Resolution time of intraretinal cysts and sub retinal fluid on OCT

    Measured: 12 months

Secondary outcomes (8)

  1. Mean change in OCT central foveal thickness

    Measured: 12 months

  2. The percentage of subjects with no fluid on OCT

    Measured: 12 months

  3. The percentage of subjects who lose less than 15 letters of visual acuity

    Measured: 12 months

  4. The percentage of subjects who gain greater than or equal to 15 letters of visual acuity

    Measured: 12 months

  5. Mean change in visual acuity

    Measured: 12 months

  6. Mean change in macular volume

    Measured: 12 months

  7. Quantitative change in area (microns) from baseline in choroidal neovascular lesion characteristics/size as measured by ICG/FA/Fundus photos

    Measured: 12 months

  8. Mean number of injections of 2.0 mg intravitreal aflibercept injection

    Measured: 12 months

Timeline

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

  1. First posted6 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionNov 2014
  4. Study completionDec 2017 (estimated)

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01657669
Sponsor's protocol ID
GS-01-12
Status last verified
Oct 2017
First submitted
2 Aug 2012
Last updated
27 Oct 2017
Results posted
No
Data monitoring committee
No

Publications

  • Liu EM, Shah G, Blinder KJ, Smith BT, Thomas MA. Intravitreal Aflibercept for Neovascular AMD: Short-Term Clinical Effects of Intravitreal Aflibercept Injection as a Predictor of Long-Term Results. Ophthalmic Surg Lasers Imaging Retina. 2015 Nov-Dec;46(10):1021-7. doi: 10.3928/23258160-20151027-06.

    PubMed 26599244

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal Aflibercept injection in people with Age Related Macular Degeneration, run by Retina Research Institute, LLC at 3 sites in United States.

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 4 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: status not confirmed, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Results are not available in the source record.

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?

Resolution time of intraretinal cysts and sub retinal fluid on OCT (time frame: 12 months). 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 NCT01657669, which also lists 1 linked publication.

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 27 Oct 2017.

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