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Diabetic Macular EdemaPhase 4PRESERVENCT01486238

Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study

A Phase 4 study testing Macugen® pegaptanib sodium in people with Diabetic Macular Edema, run by Valley Retina Institute 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
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Trial summary

Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic Macular Edema (DME), as compared to injections every 6 weeks. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
Macugen® pegaptanib sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteUnited States
Study dates
Apr 2009to Oct 2011
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must have macular edema that involves the center of the macula with corresponding leakage on fluorescein angiogram.
  • Foveal thickness of at least 250 microns (OCT center point thickness), with a standard deviation of the center point of <10%, an OCT signal strength of > 5, and properly drawn ILM and RPE borders.
  • Best corrected distance visual acuity in the study eye must 137 be a letter score between 70 and 20 inclusive (20/40 to 20/400 Snellen equivalents).
  • Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
  • Intraocular pressure (IOP) of 21 mmHg or less (local anti-hypertensive medication of any duration permitted).
  • The treating ophthalmologist should be comfortable that focal laser (direct and grid as needed) can be deferred for at least 18 weeks in the study eye, even though focal laser is indicated.
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  • Type I, or Type II diabetic subjects, of both genders, and aged 18 years.
  • Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. All women of childbearing potential must have a negative serum pregnancy test at baseline and negative urine pregnancy tests immediately prior to each injection and use two effective forms of contraception during the trial and for at least 60 days following the last dose of pegaptanib sodium.
  • Ability to provide written informed consent.
  • Ability to return for all study visits.

Who cannot join

  • Eyes in which panretinal photocoagulation is needed now or is likely to be needed within the next 6 months.
  • Eyes that have active PDR with high risk characteristics (HRC) as defined by the DRS:
  • Mild neovascularization of the disc (NVD) of at least 1/3 disc area as shown in standard photograph 10A of the DRS.
  • Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc area as shown in standard photograph 7 of the DRS.
  • Presence of any abnormality that is likely to confound assessment of visual acuity improvement in eyes in which macular edema resolves, or improves, such as non-perfusion for >1 disc area involving the foveal avascular zone, epiretinal membrane associated with signs of contraction and/or significant opacification, or presence of chorioretinal atrophy involving the center of the macula.
  • Vitreomacular traction determined clinically and/or by OCT, which, in the investigator's opinion, contributes to the macular edema (or causes associated foveal detachment), and would preclude improvement with pegaptanib sodium
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  • Any other cause of macular edema such as vitreous extension, or entrapment to anterior segment wound, or any retinal vein occlusion involving the macula.
  • Any subfoveal hard exudates, or RPE atrophy; or any present evidence, or past documentation of a foveal cyst (by fundus examination, FA or OCT).
  • Previous treatment with intravitreal corticosteroids in the study eye within 3 months of Day 0 visit.
  • Previous treatment with intravitreal anti-angiogenic drugs in the study eye within 3 months of Day 0 visit.
  • Previous PRP laser treatment in the study eye within 90 days of Day 0 visit.
  • Subjects who have received YAG laser or peripheral retinal cryoablation or laser retinopexy (for retinal tears only), or focal photocoagulation within the previous 16 weeks.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Valley Retina Institute,PA

    McAllen, Texas, 78503

Other trials in United States

About this study

Intravitreal injections of pegaptanib every 4 weeks will be efficacious in treating Diabetic Macular Edema (DME), as compared to injections every 6 weeks.

Read the detailed description

This is a 24 week clinical study which will be double-masked. Subjects will be randomly assigned 2:1 to Macugen® every 4 weeks (IVMac q4 arm) or Macugen® every 6 weeks (IVMac q6 arm). If both eyes are eligible, then one eye will be randomized into the trial. Fellow eyes of patients with two eligible eyes will be monitored and treated with standard clinical care. If sufficient fellow eyes are treated, this will provide an internal control group for direct comparison of the Macugen® treated study eyes versus the fellow eyes. Both study eyes and fellow eyes will be assessed in the same fashion at every time point during this study.

Each site is to have at least one Unmasked investigator to perform the study injections and one Masked investigator to perform study evaluations and assess adverse events. Roles cannot be reversed after study treatment for a given subject has begun.

Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6 week intervals beginning on Day 0 and ending at Week 18. Each Macugen® injection will be administered as described in the package insert.

Being tested
Macugen® pegaptanib sodium
Keywords
Diabetic Macular Edema

What participants receive

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

  • Macugen® pegaptanib sodiumDrug

    Also called Macugen® (pegaptanib sodium)

    Patients assigned to either arm (IVMac q4 and IVMac q6) will receive 0.3 milligrams (mg) of pegaptanib sodium delivered by intravitreal injection administered.

    Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6 week intervals beginning on Day 0 and ending at Week 18. Each Macugen® injection will be administered as described in the package insert.

Study groups in NCT01486238
Study groupRoleWhat they receive
IVMac q6 ArmExperimentalPatients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
Receives: Drug: Macugen® pegaptanib sodium
IVMac q4 ArmExperimentalPatients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
Receives: Drug: Macugen® pegaptanib sodium

What is being measured

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

  1. Proportion of Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline.

    The primary efficacy outcome measure is the proportion of subjects who gain two or more lines in BCVA score in the Study Eye compared with baseline at 24 weeks. The BCVA is to be measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol.

    Measured: 24 weeks

Secondary outcomes (2)

  1. Mean Change From Baseline at Week 24 in Central Foveal Thickness

    Optical Coherence Tomography (OCT) will be used to assess the central foveal thickness of each patient. The mean change from baseline to week 24 will be calculated for each patient.

    Measured: 24 Weeks

  2. Proportion of Subjects Requiring Macular Laser Treatment at Week 12 and Week 24.

    There is a possibility that some subjects may not respond to the study treatment to which they have been assigned. Macular laser treatment is considered an alternative treatment for retinal edema. A lower proportion of subjects requiring macular laser treatment would indicate a superior treatment regimen.

    This will be assessed at week 12, and again at week 24.

    Measured: 24 weeks

Timeline

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

  1. First posted6 Dec 2011 (estimated)
  2. Study startApr 2009
  3. Primary completionJul 2011
  4. Study completionOct 2011

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01486238
Sponsor's protocol ID
PRESERVE
Acronym
PRESERVE
Status last verified
Jun 2013
First submitted
2 Dec 2011
Last updated
16 Jul 2013
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Macugen® pegaptanib sodium in people with Diabetic Macular Edema, run by Valley Retina Institute at 1 site 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 10 inclusion and 12 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 16 Jul 2013. 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 16 Jul 2013). 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 Subjects Who Gain Two or More Lines in Best Corrected Visual Acuity(BCVA) Score in the Study Eye Compared With Baseline. (time frame: 24 weeks). 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 NCT01486238.

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 16 Jul 2013.

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