ISRCTN - ISRCTN66216819: OCTOME study

Plain English Summary

Background and study aims
Macular oedema is the most common cause of visual impairment in retinal vascular diseases (diseases affecting the blood vessels of the eyes). Ozurdex is a biodegradable implant injected into the eye and containing a medication called dexamethasone. The implant is slowly dissolved in the eye, releasing the drug. It has been tested in other studies based on 6 monthly dosing but the results indicated that the effect of the drug may wear off earlier. The aim of this project was to monitor the visual acuity (how clear the vision is) and macular thickness (thickness of an oval-shaped pigmented area near the retina of the eye) every month to determine at which point the dosing of Ozurdex provides the maximal effect and correlate structural changes (of the eye) with visual acuity.

Who can participate?
Adults with macular oedema.

What does the study involve?
All participants are treated with Ozurdex and the their progress followed up every 4 weeks for the next 36 weeks. If sufficient progress has not been made (for example, if macular thickness has not increased sufficiently) one extra treatment is allowed between weeks 16 and 24.

What are the possible benefits and risks of participating?
Participants may benefoit from successful treatment of their macular oedema. Potential risks include glaucoma and progression or development of cataracts.

Where is the study run from?
King's College Hospital NHS Foundation Trust

When is the study starting and how long is it expected to run for?
June 2011 to December 2012

Who is funding the study?
Allergan (UK)

Who is the main contact?
Dr Sobha Sivaprasad

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sobha Sivaprasad

ORCID ID

http://orcid.org/0000-0001-8952-0659

Contact details

King's College Hospital NHS Foundation Trust
Normanby Building
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

11/H0718/6

Study information

Scientific title

An exploratory phase III prospective open-label clinical study on monthly Optical Coherence Tomography (OCT) monitoring of the effects of Ozurdex for macular oedema related to retinal vascular diseases (OCTOME Study)

Acronym

OCTOME study

Study hypothesis

Ozurdex was given every 6 months, if indicated, in the GENEVA trial on Ozurdex for macular oedema secondary to retinal vascular occlusions The study results indicated that the maximum effect of the drug was at 3-4 months based on visual acuity data. The trial was not designed to monitor the anatomical effect every month. This is essential to understand the morphological impact of the drug. Visual acuity does not always correlate with clinical severity of macular oedema so other visual functions such as contrast sensitivity and colour vision and retinal sensitivity will give us a better understanding of the effect of Ozurdex on macular oedema.

Ethics approval

Central London REC 1, 11/04/2011, ref: 11/H0718/6

Study design

Exploratory Phase III prospective study on 30 patients with macular oedema secondary to retinal vascular disorders treated with OCT guided OZURDEX and monitored for 36 weeks.

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Macular oedema

Intervention

1. Ozurdex 700µg dose intravitreal implant will be given to all patients at baseline
2. Patients will then be followed up 4 weekly for 36 weeks
3. Re-treatment with the same drug is allowed at 16th, 20th or 24th week
4. Each patient will receive a maximum of 2 injections
5. Re-treatment is allowed from week 16 to 24 inclusive if the following criteria are met after an initial improvement (reduction) of macular thickness of at least 50 μm:
5.1. Average macular thickness increases by 100 μm or more from the last visit AND
5.2. At least a 5 letter drop in BCVA score from the previous visit
5.3. However, please note that a second injection should not be administered if the patient experienced raised IOP above 30mmHg at any point
6. The last follow up for patients included in the study will be at week 36
7. All patients will have an additional visit for a safety check 5-7 days after treatment(s)

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measure

Mean change in OCT at 4 weekly time points

Secondary outcome measures

1. Mean change in macular thickness at week 24
2. Mean change in visual acuity at week 24
3. Proportion with gain of 15 ETDRS letters or more (improvement) from screening at week 24
4. Proportion with loss less than 15 ETDRS letters (stabilization) from screening at week 24
5. Proportion of patients with gain of 0, 5 and 10 letters from screening at week 24
6. Mean Change in other visual functions at week 24:
6.1. Change in contrast sensitivity
6.2. Change in colour vision
6.3. Change in reading vision
6.4. Change in microperimetry thresholds
6.5. Change in fixation on microperimetry
7. Efficacy parameters that will be assessed at week 36:
7.1. Mean change in visual acuity and macular thickness at week 36
7.2. Proportion with gain of 15 ETDRS letters or more (improvement) from screening at week 36
7.3. Proportion with loss less than 15 ETDRS letters (stabilization) from screening at week 36
7.5. Proportion of patients with recurrence of oedema (increase macular thickness by 100µm from baseline to 36 weeks at each 4 weekly time point from baseline

Overall trial start date

08/06/2011

Overall trial end date

08/12/2012

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged 18 or above
2. Ability to provide informed consent
3. Diagnosis of macular oedema secondary to diabetic maculopathy, branch and central retinal vein occlusion or pseudophakic cystoid macular oedema or post-inflammatory macular oedema
4. Central macular thickness on OCT should be above 250µm
5. Best corrected visual acuity in the study eye between 37 and 68 letters

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Any other eye disease which could mask macular oedema
2. Known uncontrolled systemic disease or current immunosuppressive disease
3. Initiation of medical therapy for diabetes or a change from oral hypoglycaemic agents to insulin therapy within 4 months prior to the screening visit
4. Renal failure requiring haemodialysis or peritoneal dialysis within 6 months prior to screening visit
5. Any ocular condition in the study eye that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (e.g., severe macular ischemia, extensive macular laser scarring or atrophy)
6. Presence of an epiretinal membrane or vitreo-retinal interface changes in the study eye which, in the opinion of the investigator, is the primary cause of macular oedema, or is severe enough to prevent improvement in visual acuity despite reduction in macular oedema
7. Active or suspected ocular or periocular infection including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases
8. Advanced glaucoma which cannot be adequately controlled by medicinal products alone
9. History of IOP elevation in response to steroid treatment in either eye that resulted in any of the following:
9.1. >10 mm Hg increase in IOP from baseline with an absolute IOP > 25 mm Hg
9.2. Required therapy with 3 or more anti-glaucoma medications
10. Pregnancy if child bearing age (confirmed by pregnancy test) and to avoid pregnancy during the 36 weeks of the study. Pregnancy test will not be done in post-menopausal women (defined as 12 months post LMP)
11. Breast feeding women will be excluded
12. Hypersensitivity to the active substance or to any of the excipients
13. Inability to provide informed consent

Recruitment start date

08/06/2011

Recruitment end date

08/12/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College NHS Foundation Trust (UK)

Sponsor details

Joint Clinical Trials Office
Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom