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

NCT01486238 | Completed Phase 4 Results

• 1 other identifier: PRESERVE
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (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.

  24 weeks

Secondary Outcomes (2)

• Mean Change From Baseline at Week 24 in Central Foveal Thickness

  24 Weeks

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

  24 weeks

Study Arms (2)

IVMac q6 Arm

EXPERIMENTAL

Patients 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.

Drug: Macugen® pegaptanib sodium

IVMac q4 Arm

EXPERIMENTAL

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. Macugen® injection will be administered as described in the package insert.

Drug: Macugen® pegaptanib sodium

Interventions

Macugen® pegaptanib sodium DRUG

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.

Also known as: Macugen® (pegaptanib sodium)

IVMac q4 Arm; IVMac q6 Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Valley Retina Institute: lead

Study Sites (1)

Valley Retina Institute,PA

McAllen, Texas, 78503, United States

Location

MeSH Terms

Interventions

pegaptanib

Results Point of Contact

• Title: Victor Gonzalez, MD
• Organization: Valley Retina Institute, PA

research@vritx.com

956-631-8875

Study Officials

• Victor Gonzalez, Dr.

  Valley Retina Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2011
• First Posted: December 6, 2011
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: October 1, 2011
• Last Updated: July 16, 2013
• Results First Posted: July 16, 2013

Record last verified: 2013-06

Locations

US (1)