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A prospective randomised controlled trial assessing the efficacy of Pegatanib sodium (Macugen®) in the prevention of proliferative diabetic retinopathy

A prospective randomised controlled trial assessing the efficacy of Pegatanib sodium (Macugen®) in the prevention of proliferative diabetic retinopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN27864936
Enrollment
90
Registered
2010-04-29
Start date
2009-01-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Eye

Interventions

90 subjects with ETDRS 53 A - E will be enrolled into the study. Baseline examination will include of best-corrected visual acuity (BCVA), fundus examination, 7-field retina colours and fundus fluores

Sponsors

Frimley Park Hospital NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Not provided at time of registration

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
The proportion of eyes that progress to ETDRS = 61 following three injections of intravitreal Macugen®

Secondary

MeasureTime frame
1. The mean change in size of foveal avascular zone (FAZ) from baseline to end of 12 months and 24 months 2. The rate (timepoint) of development of neovascularisation 3. Rates of ocular and non-ocular adverse events 4. The visual outcome in the study eye will be compared to control eyes

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026