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 |
| Secondary identifying numbers | 6648 |
- 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
| Study design | Randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pegatanib sodium (Macugen®) |
| Primary outcome measure | The proportion of eyes that progress to ETDRS = 61 following three injections of intravitreal Macugen® |
| Secondary outcome measures | 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 |
| Overall study start date | 01/01/2009 |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned Sample Size: 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
- England
- United Kingdom
Study participating centre
Frimley Park Hospital
Surrey
GU16 7UJ
United Kingdom
GU16 7UJ
United Kingdom
Sponsor information
Frimley Park Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Maple House
Portsmouth Road
Frimley
Surrey
GU16 7UJ
England
United Kingdom
| Website | http://www.frimleypark.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/00mrq3p58 |
Funders
Funder type
Industry
Pfizer (UK)
Government organisation / For-profit companies (industry)
Government organisation / For-profit companies (industry)
- Alternative name(s)
- Pfizer Inc., Pfizer Consumer Healthcare, Davis, Charles Pfizer & Company, Warner-Lambert, King Pharmaceuticals, Wyeth Pharmaceuticals, Seagen
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| 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
