Evaluation of the effect of Panretinal photocoagulation ( PRP ) versus PRP plus Intravitreal Bevacizumab on Macular Thickness, Macular Choroidal Thickness, Peripapillary Nerve Fiber Layer thickness by Optical Coherence Tomography in patients with diabetic retinopathy.
This study is a single- blind randomized clinical trial which has been designed to determine the best treatment plan for diabetic retinopathy according to Macular Thickness, Macular Choroidal Thickness and Peripapillary RNFL Thickness.
Patients with type 1 or 2 diabetes with Severe Nonproliferative diabetic retinopathy or Proliferative diabetic retinopathy in both eyes who have been referred to Farabi eye hospital retina clinic will be included. The exclusion criteria may include any type of previous retinal treatment and other retinal or optic nerve disease. The target sample size is 42 eyes in each group (according to a pilot study that has been done).
Each eye will undergo SD-OCT then Panretinal Photocoagulation (PRP) will be done at 3 sessions. After first PRP, one intravitreal injection of 1.25 mg of Bevacizumab will be performed randomly in one of the each patient′ eye. The patients will be followed with best corrected visual acuity (BCVA) and OCT at months 1, 3 and 6.
Additional PRP in control group and intravitreal injection of 1.25 mg of Bevacizumab in treatment group will be performed if retreatment is needed at months 3 and 6.
Macular Photocoagulation will be performed at first visit, months 3 and 6 if patients have clinically significant macular edema (either treatment or control group).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030116782N1
Registration date:2014-12-22, 1393/10/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Ramak Roohipoor
Name of organization / entity
Farabi Eye Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1001
Email address
roohipoor@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences, Farabi Hospital, Ophthalmic Research Center
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Panretinal photocoagulation ( PRP ) versus PRP plus Intravitreal Bevacizumab on Macular Thickness, Macular Choroidal Thickness, Peripapillary Nerve Fiber Layer thickness by Optical Coherence Tomography in patients with diabetic retinopathy.
Public title
The effect of laser on eye in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Presence of severe Nonproliferative diabetic retinopathy or Proliferative diabetic retinopathy in both eyes; Normal intraocular pressure; Refractive error within ±3 diopter (D).
Exclusion criteria: Any type of previous retinal treatment ( macular or peripheral laser photocoagulation, vitrectomy, intravitreal steroids and/or antiangiogenic drugs); Glaucoma or ocular hypertension; Significant media opacities that precluded fundus examination or imaging; Other retinal or optic nerve disease; Uncontrolled systemic hypertenion (BP ≥ 180/110); Central macular thickness ≥ 350
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University Of Medical Sciences
Street address
Ghods Street, Enghelab Square
City
Tehran
Postal code
Approval date
2014-10-23, 1393/08/01
Ethics committee reference number
م پ/ 0928
Health conditions studied
1
Description of health condition studied
Diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy
Primary outcomes
1
Description
macular thickness
Timepoint
before intervention, 1, 3 and 6 months after intervention
Control group(PRP): PRP treatment by an argon green laser with a retinal spot size of 500 ϻm and moderate intensity(until a hazy, mucoid and translucent choroidal lesion become evident), the duration of the 0.2 second and the total number of spots 1200- 1600, at 3 sessions; Additional PRP at 3 and 6 months, if retreatment is needed; Macular Photocoagulation(MPC)at first visit or 3 and 6 months, if patients have clinically significant macular edema(CSME).
Category
Treatment - Other
2
Description
Treatment group(PRP plus IVB): PRP treatment by an argon green laser with a retinal spot size of 500 ϻm and moderate intensity(until a hazy, mucoid and translucent choroidal lesion become evident), the duration of the 0.2 second and the total number of spots 1200- 1600, at 3 sessions; One intravitreal injection of 1.25 mg of Bevacizumab in one of the patients′ eyes randomly, 120 min after completion of the first PRP session; Intravitreal injection of 1.25 mg of Bevacizumab, at 3 and 6 months, if retreatment is needed; Macular Photocoagulation(MPC)at first visit or 3 and 6 months, if patients have clinically significant macular edema(CSME).
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Dr.Fariba Ghasemi
Street address
Southern Kargar Street, Qazvin Square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University Of Medical Sciences, Farabi Hospital, Ophthalmic Research Center