A prospective randomised controlled trial assessing the efficacy of Pegatanib sodium (Macugen®) in the prevention of proliferative diabetic retinopathy
| ISRCTN | ISRCTN27864936 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27864936 |
| Protocol serial number | 6648 |
| Sponsor | Frimley Park Hospital NHS Foundation Trust (UK) |
| Funder | Pfizer (UK) |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 14/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Narinder Sangha
Scientific
Scientific
Frimley Park Hospital
Maple House
Surrey
GU16 7UJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional treatment trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A prospective randomised controlled trial assessing the efficacy of Pegatanib sodium (Macugen®) in the prevention of proliferative diabetic retinopathy |
| Study acronym | Macugen® |
| Study objectives | Multi-centre prospective randomised controlled study to assess the efficacy of intravitreal Macugen® injections to prevent the development of proliferative diabetic retinopathy (early treatment diabetic retinopathy study [ETDRS] = 61) compared to standard care (no treatment) in patients with severe non-proliferative diabetic retinopathy (sNPDR) (ETDRS = 53 A - E). The objective of the study is to assess whether Macugen® given at these time points of diabetic retinopathy can prevent the conversion to sight threatening PDR. |
| Ethics approval(s) | MREC approved (ref: 08/H1102/91) |
| Health condition(s) or problem(s) studied | Topic: Eye; Subtopic: Eye (all Subtopics); Disease: Ophthalmology |
| Intervention | 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 fluorescein angiography with peripheral sweeps. The patients in the treatment arm will have 3 injections of intravitreal Macugen® 0.3 mg at baseline, 6 weeks and 12 weeks. All patients will be followed up at 12 weekly intervals. Treatment group: baseline, week 6, 12, 24, 36, 48, 60, 72, 84, 96 and 108 weeks Control arm: baseline, 12, 24, 36, 48, 60, 72, 84, 96 and 108 weeks Follow up investigation include BCVA, fundus examination and 7-field retinal colour photographs at every visit. FFA with peripheral sweeps will be done at 12, 36, 60, 84 and 108 weeks follow-up. Pan retinal photocoagulation (PRP) will be carried out at any visit if the level of retinopathy progresses to ETDRS = 61. Subjects will be evaluated for ocular and systemic adverse events at all visits and any unscheduled visits. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pegatanib sodium (Macugen®) |
| Primary outcome measure(s) |
The proportion of eyes that progress to ETDRS = 61 following three injections of intravitreal Macugen® |
| Key secondary outcome measure(s) |
1. The mean change in size of foveal avascular zone (FAZ) from baseline to end of 12 months and 24 months |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Target sample size at registration | 90 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Frimley Park Hospital
Surrey
GU16 7UJ
United Kingdom
GU16 7UJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/07/2016: No publications found, study status unverified
