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The purpose of this study is to assess whether preoperative pegaptanib sodium safely improves vitreous hemorrhage prior to surgical intervention and to evaluate the stability of pre-existing tractional retinal detachment.
Patients undergoing pars plana vitrectomy for active PDR with TRD will receive a single intravitreal pre-operative 0.3mg Macugenâ„¢ prior to surgery versus sham injection.
Specific timing of the injection will be at no sooner than 7 days and no longer than 14 days prior to surgery.
Patients will receive a preinjection fundus photo and another post injection photo the day of surgery as dictated by the operative schedule.
Some photos may be limited secondary to vitreous hemorrhage. Follow up visits after surgery will be one day, one week, one month, and three months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.3mg Pegaptanib Sodium, Macugen | Experimental | will receive Macugen intravitreal injection prior to surgery |
|
| Sham injection | Sham Comparator | will receive a sham injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Macugen | Drug | one intravitreal injection of Macugen prior to vitrectomy surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tractional Retinal Detachment Repair | Overall score of perceived improvement during surgery as determined by a surgeon's subjective questionnaire. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post surgical interventions | Post surgical interventions including need for additional surgery, additional injections or PRP laser | 6 Months |
| Vitreous Hemorrhage and Tractional Retinal Detachment Improvement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C Major, MD | PI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19692371 | Background | Gonzalez VH, Giuliari GP, Banda RM, Guel DA. Intravitreal injection of pegaptanib sodium for proliferative diabetic retinopathy. Br J Ophthalmol. 2009 Nov;93(11):1474-8. doi: 10.1136/bjo.2008.155663. Epub 2009 Aug 18. | |
| 19875087 | Background | Wroblewski JJ, Wells JA 3rd, Gonzales CR. Pegaptanib sodium for macular edema secondary to branch retinal vein occlusion. Am J Ophthalmol. 2010 Jan;149(1):147-54. doi: 10.1016/j.ajo.2009.08.005. Epub 2009 Oct 28. |
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| Sham | Drug | The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery. |
|
Pre and perioperative fundus photo comparisons on an objective scale
| 6 months |
| Adverse Events | Incidence and severity of ocular and nonocular adverse events, such as redetachment, progression to neovascular glaucoma, endophthalmitis, etc. through post operative month 3 | 6 months |
| Visual Acuity | Visual acuity as measured by BCVA | 6 months |
| 16829817 | Background | Chen E, Park CH. Use of intravitreal bevacizumab as a preoperative adjunct for tractional retinal detachment repair in severe proliferative diabetic retinopathy. Retina. 2006 Jul-Aug;26(6):699-700. doi: 10.1097/01.iae.0000225351.87205.69. No abstract available. |
| 37260074 | Derived | Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4. |
| ID | Term |
|---|---|
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D005130 | Eye Hemorrhage |
| D005128 | Eye Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
| C005703 | salicylhydroxamic acid |
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