Pegaptanib for Retinal Edema Secondary to Diabetic Vascular Disease(Preserve) Study
Condition: Diabetic Macular Edema
MeSH terms: Papilledema; Macular Edema; Vascular Diseases; Diabetic Angiopathies; Edema
Intervention: Macugen® pegaptanib sodium
Intervention description: 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.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have macular edema that involves the center of the macula with
             corresponding leakage on fluorescein angiogram.

          2. 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.

          3. 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).

          4. Clear ocular media and adequate pupillary dilatation to permit good quality
             stereoscopic fundus photography.

          5. Intraocular pressure (IOP) of 21 mmHg or less (local anti-hypertensive medication of
             any duration permitted).

          6. 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.

          7. Type I, or Type II diabetic subjects, of both genders, and aged 18 years.

          8. 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.

          9. Ability to provide written informed consent.

         10. Ability to return for all study visits.

        Exclusion Criteria:

          1. Eyes in which panretinal photocoagulation is needed now or is likely to be needed
             within the next 6 months.

          2. Eyes that have active PDR with high risk characteristics (HRC) as defined by the DRS:

               1. Mild neovascularization of the disc (NVD) of at least 1/3 disc area as shown in
                  standard photograph 10A of the DRS.

               2. Moderate neovascularization of the retina elsewhere (NVE) of at least 1/2 disc
                  area as shown in standard photograph 7 of the DRS.

          3. 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.

          4. 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

          5. Any other cause of macular edema such as vitreous extension, or entrapment to anterior
             segment wound, or any retinal vein occlusion involving the macula.

          6. Any subfoveal hard exudates, or RPE atrophy; or any present evidence, or past
             documentation of a foveal cyst (by fundus examination, FA or OCT).

          7. Previous treatment with intravitreal corticosteroids in the study eye within 3 months
             of Day 0 visit.

          8. Previous treatment with intravitreal anti-angiogenic drugs in the study eye within 3
             months of Day 0 visit.

          9. Previous PRP laser treatment in the study eye within 90 days of Day 0 visit.

         10. 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.