Intravitreal pegaptanib for the treatment of ischemic diabetic macular edema

Figures & data

Table 1 Objectives

Primary	Secondary
To determine the effect of a series of five 6-weekly injections of intravitreal pegaptanib on the size of the FAZ in DME with macular ischemia	To determine how a series of five 6-weekly injections of intravitreal pegaptanib affects central subfield thickness and BCVA in DME with macular ischemia

Abbreviations: FAZ, foveal avascular zone; DME, diabetic macular edema; BCVA, best-corrected visual acuity.

Figure 1 Fundus fluorescein angiogram at 45 seconds in a patient with ischemic diabetic macular edema.

Table 2 Inclusion and exclusion criteria

Inclusion

Exclusion

• Participant is willing and able to give informed consent for participation in the study • Male or female, aged 18 years or above • Participant has DME • BCVA 20/32 to 20/320 inclusive • Central OCT thickness >300 μm • Enlargement of FAZ (ischemia or capillary drop out of >30% on FFA) • Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter • Able (in the investigator’s opinion) and willing to comply with all study requirements, for example, attending for tests and treatment every 6 weeks • Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study

• Any coexisting ocular disease (with the exception of cataract) • Female participants who are pregnant, lactating, or planning pregnancy during the course of the study • Any significant disease or disorder, for example, recent stroke or myocardial infarction, which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant’sability to participate in the study • Significant renal impairment, that is, creatinine clearance <20 mL/min • Participants who have participated in another research study involving an investigational product in the past 12 weeks • Within 3 months of laser treatment • Intraocular surgery within 6 months • Known allergy to pegaptanib • Known allergy to fluorescein

Abbreviations: DME, diabetic macular edema; BCVA, best-corrected visual acuity; FAZ, foveal avascular zone; FFA, fundus fluorescein angiogram; OCT, optical coherence tomography.

Figure 2 Mean change in FAZ area over 30 weeks.

Abbreviation: FAZ, foveal avascular zone.

Figure 3 Mean change in CST over 30 weeks.

Abbreviation: CST, central subfield thickness.

Figure 4 Change in BCVA over 30 weeks.

Abbreviation: BCVA, best-corrected visual acuity.

Table 3 Summary of results

Patient group	Number of patients	Mean age (years)	Outcome measure	Baseline	End of study	P-value
Whole group	30	66.5	FAZ (pixels)	964	987	0.771
			CST (μm)	491	451	0.128
			BCVA (letters)	47.8	49.7	0.476
Mild/moderate ischemia	16	68.9	FAZ (pixels)	441	538	0.335
(FAZ area <1,000 pixels)			CST (μm)	512	439	0.114
			BCVA (letters)	45.3	47.8	0.587
Severe ischemia	14	63.7	FAZ (pixels)	1,562	1,500	0.624
(FAZ >1,000 pixels)			CST (μm)	467	466	0.938
			BCVA (letters)	50.6	51.9	0.644
Those who completed the full course of treatment	27	67.0	FAZ (pixels)	973	946	0.734
			CST (μm)	478	424	0.052
			BCVA (letters)	49.2	53.9	0.046

Abbreviations: FAZ, foveal avascular zone; CST, central subfield thickness; BCVA, best-corrected visual acuity.

Figure 5 Example of a patient who benefitted from treatment.

Notes: Note the reduction in macular edema on OCT with minimal change in the size of the FAZ. (A) FAZ at baseline. (B) FAZ after five pegaptanib injections. (C and E) OCT scan at baseline. (D and F) OCT scan after 5 pegaptanib injections.
Abbreviations: FAZ, foveal avascular zone; OCT, optical coherence tomography; BCVA, best corrected visual acuity.