E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Open Angle Glaucoma |
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E.1.1.1 | Medical condition in easily understood language |
Raised eye pressure causing damage to the optic nerve, for which no cause can be found. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030348 |
E.1.2 | Term | Open angle glaucoma |
E.1.2 | System Organ Class | 10015919 - Eye disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary aim of the pilot study is to assess acceptability of the proposed treatment to patients, evaluate our trial SOPs such as randomisation and masking, and to gather information on the efficacy and safety of the new treatment combination which will be used to design a definitive randomized controlled study.
Objectives 1) To gather information on the safety profile of the proposed therapy 2) To assess recruitment rates 3) To gather information of different outcome measures (intraocular pressure, bleb morphology, number of post-operative interventions, time to failure, number of topical ocular hypotensive agents after surgery, complications).
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E.2.2 | Secondary objectives of the trial |
Secondary Outcome 1) To gather information on different outcome measures (intraocular pressure, bleb morphology, number of post-operative interventions, time to failure, number of topical ocular hypotensive agents after surgery, complications).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria: All of the criteria listed below must be present in order for the patient to be eligible for enrolment in the study.
1. Age 18 to 85 years, inclusive 2. Patient must have undergone standard trabeculectomy augmented with Mitomycin C, within the past 4-6 weeks. 3. Patients who in the clinician’s opinion are mounting an aggressive wound healing response and demonstrate objective increase in bleb vascularity (moderate or severe on MBGS). |
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E.4 | Principal exclusion criteria |
If any of the following exclusion criteria are present, the patient will not be entered into the study.
1. Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits. 2. Pregnant or nursing women. 3. A history of cardiovascular or cerebrovascular events in the previous 6 months, such as angina, arrhythmia, Transient Ischaemic Attack, strokes, myocardial infarction. 4. Uncontrolled hypertension defined as systolic blood pressure >160mmHg or diastolic blood pressure >90mmHg 5. Subject hypersensitive to bevacizumab, 5-FU, and mitomycin-C and its excipients
The following exclusions apply to the study eye only (i.e. they may be present for the non study eye
6. No light perception. 7. Aphakia 8. Previous ocular surgery: vitreo-retinal, conjunctival surgery 9. Complicated cataract surgery 10. Cataract surgery less than 6 months in duration 11. Secondary glaucoma, other than PDS and PXF 12. Ocular trauma within the past 3 months 13. Active iris neovascularization or active proliferative retinopathy. 14. Severe posterior blepharitis. 15. Unwilling to discontinue contact lens use after surgery. 16. Conjunctival scarring precluding a superior trabeculectomy. 17. Need for glaucoma surgery combined with other ocular procedures (ie cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery. 18. Current or recent (<3months) use of bevacizumab into the study eye. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The Primary Outcome measures are: 1) Time taken to recruit 30 subjects (from start of study) 2) Proportion of patients who are eligible, who agree to be randomised 3) Proportion of patients who are lost to follow-up or who withdraw from the study.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The evaluation will take place 18 months after LVLS |
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E.5.2 | Secondary end point(s) |
Secondary outcome measures are: 1. Intraocular pressure 2. Bleb morphology (as determined by Moorfields Bleb Grading system) 3. Number of additional postoperative interventions with 5-fluorouracil (5-FU) and subconjunctival dexamethasone, following the 4 week trial intervention period; bleb needling. (received between surgery and 18 months of follow up) 4. Time to failure 5. Number of topical ocular hypotensive medications at 3 months and 18 months 6. The incidence of the following complications will be recorded: hypotony (IOP < 6mmHg at 2 consecutive post-operative visits after 3 months), hypotony maculopathy, wound leakage and bleb leakage, bleb-related infections (blebitis, bleb-related endophthalmitis).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The evaluation will take place 18 months after LVLS |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 30 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 30 |