Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000511639
Ethics application status
Approved
Date submitted
12/04/2014
Date registered
13/05/2014
Date last updated
13/05/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic Ranibizumab in the fellow eye in patients with wet type Age Related Macular Degeneration
Scientific title
Prophylactic Ranibizumab in the fellow eye in patients with wet type Age Related Macular Degeneration
Secondary ID [1] 284434 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wet Age Related Macular Degeneration (AMD) 291638 0
Condition category
Condition code
Eye 292023 292023 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ranibizumab injection is a prescription medicine for the treatment of patients with neovascular (wet) AMD with satisfactory results, our clinical observation is that once the eye enter wet AMD it will never regain best corrected visual acuity like before the disease process so if we can use ranibizumab injection as a prophylactic in the sound eye in patient suffering from manifestations of Wet AMD in the other eye, it will be a good achievement.
Ranibizumab is injected intravitreally with a dose of 6 mg/mL LUCENTIS (0.3 mg dose vial).injection applied 3 times (one every six months). the follow up for two years.
The progression of the disease is monitored with two investigations
1- fluorescine angiography.
2- optical coherence tomography
Intervention code [1] 289185 0
Treatment: Drugs
Intervention code [2] 289368 0
Prevention
Comparator / control treatment
The other eye of patient with wet AMD will undergo follow up for two years without treatment.
The progression of the disease is monitored with two investigations
1- fluorescine angiography.
2- optical coherence tomography
Control group
Active

Outcomes
Primary outcome [1] 291910 0
the primary outcome represent how the sound eye survived from wet AMD with the aid of intravitreal injection. The eye examined at frequent intervals with optical coherent tomography and fluorescine angiography to found early changes in the retina.
Timepoint [1] 291910 0
two years follow up of patients with active intervention or no treatment.
Secondary outcome [1] 307797 0
to observe rate of progression of AMD in the sound eye in no treatment group.The eye examined at frequent intervals with optical coherent tomography and fluorescine angiography to found early changes in the retina.
Timepoint [1] 307797 0
to observe rate of progression of AMD in the sound eye in no treatment group during a follow up of two years.

Eligibility
Key inclusion criteria
1- Must be greater than 50 years of age.
2- Must have a good 5-yr prognosis.
3- Must be diagnosed with age-related macular degeneration.
4- Must be likely to be available, willing, and able to undergo examinations at 6-mo intervals for 5 yrs.
5- Must understand and be willing to give signed informed consent.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
General exclusion criteria :
1-Chronic alcoholism or drug abuse.
2- Personality disorder or use of major tranquilizers (e.g., haloperidol,phenothiazine), indicating difficulty in long-term follow-up.
3- Allergy to sodium fluorescein.
Ocular exclusion criteria:
1-For bilateral patients, a BCVA equal to 20/63 on an ETDRS chart in either eye; for unilateral patients, a BCVA equal 20/60 on an ETDRS chart in the eye being considered for treatment.
2- Advanced AMD in either eye for bilateral patients and in both eyes for unilateral patients.
3-A 5 drusen of the specified size within 2250 micron of the center of the fovea in eye(s) being considered for eligibility.
4- Retinopathy due to diabetes mellitus (more than 5 microaneurysms within the temporal Arcades.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
134 patients with Wet AMD in one eye and nearly normal other eye will be included in the study.
67 patients will receive intravitreal Ranibizumab in the better eye as prophylactic to prevent wet AMD while the other 67 patients will be followed without intervention.
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
central randomisation by computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
SAMPLE SIZE
The sample size will be calculated according to the following equation:
n=(p1q1)+ (p2q2) × F(alpha,power)
(p2-p1)


f = the value of (alpha, power) for a two-tailed test = 3.8 at significant level of 0.05
p1 = rate in group 1 = 5%
q1 = 1 – p1;
p2 = rate in group 2 = 15%
q2 = 1 – p2;
n (sample size) = 67 in each group; total sample = 134 subjects.
Collected data will coded, entered and analyzed using Microsoft Excel software. Data will then imported into Statistical Package for the Social Sciences (SPSS version 16.0) software for analysis. Baseline characteristics of the study population will presented as frequencies and percentages (%) in qualitative data or mean values and standard deviations (SD) in quantitative data. Differences between frequencies will compared by Chi-square. Differences between means were compared by Wilcoxon rank-sum test. P-value of < 0.05 was considered significant. Pearson correlation coefficient test will used to evaluate the correlations between the studied variables. Analysis Of Variance (ANOVA) test was performed for repeated measures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/06/2014
Actual
Date of last participant enrolment
Anticipated
1/04/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
134
Accrual to date
Final
Recruitment outside Australia
Country [1] 6003 0
Egypt
State/province [1] 6003 0
Ismailia

Funding & Sponsors
Funding source category [1] 289085 0
Other
Name [1] 289085 0
El Gawhara eye center ,Egypt
Country [1] 289085 0
Egypt
Primary sponsor type
Other
Name
El Gawhara eye center ,Egypt
Address
eL Gawhara eye center ,Borg el gawhara ,Ismailia station,Ismailia.
postcode 4566
Country
Egypt
Secondary sponsor category [1] 287746 0
None
Name [1] 287746 0
Address [1] 287746 0
Country [1] 287746 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290873 0
Suez Canal university hospital ethical committee
Ethics committee address [1] 290873 0
Suez Canal university hospital
km street Postcode 4356
Ismailia
Egypt
Ethics committee country [1] 290873 0
Egypt
Date submitted for ethics approval [1] 290873 0
Approval date [1] 290873 0
03/03/2014
Ethics approval number [1] 290873 0

Summary
Brief summary
1. To study the effect of intra vitreal injection of Prophylactic Ranibizumab on the development of wet type AMD in the eye with drusens in patients with preexisting neovascular AMD in the fellow eye.

2. To study the progression of drusens in the eye of patients with preexisting neovascular AMD in the fellow eye when no Treatment is given.

3. To compare between the progression drusens in the eye of patients with preexisting neovascular AMD in the fellow eye either when prophylactic Ranibizumab is injected intravitreally or with no treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47710 0
Prof ehab ghoneim
Address 47710 0
Kilo 4.5 street
Suez canal university
faculty of medicine
ophthalmology department
ismailia
6523
Country 47710 0
Egypt
Phone 47710 0
+201223639848
Fax 47710 0
Email 47710 0
[email protected]
Contact person for public queries
Name 47711 0
Prof ehab ghoneim
Address 47711 0
Kilo 4.5 street
Suez canal university
faculty of medicine
ophthalmology department
ismailia
6523
Country 47711 0
Egypt
Phone 47711 0
+201223639848
Fax 47711 0
Email 47711 0
[email protected]
Contact person for scientific queries
Name 47712 0
Prof ehab ghoneim
Address 47712 0
Kilo 4.5 street
Suez canal university
faculty of medicine
ophthalmology department
ismailia
6523
Country 47712 0
Egypt
Phone 47712 0
+201223639848
Fax 47712 0
Email 47712 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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