It is a study of two modes of treatment; which are called Laser Photocoagulation alone and with drug Triamcinolone, in the patients which are suffering from eye disease caused by Diabetes Mellitus.

Phase 4

Recruiting

• Conditions: Diabetic Macular Edema in Diabetic Retinopathy

• Registration Number: CTRI/2012/08/002878
• Lead Sponsor: Govt medical college and Sir Takhatsinhji General Hospital Bhavnagar

Brief Summary

**Thisstudy is a randomized, parallel group, open label, comparative study comparingsafety and efficacy of Laser Photocoagulation with and without  intravitreal injection Triamcinolone Acetonidein patients with clinically significant macular edema in diabetic retinopathythat will be conducted at single centre in India. The primary outcome measureswill be best corrected visual acuity and intraocular pressure measurement.**

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-09
• Last Update Posted: 2012-04-22

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1)Diagnosis of diabetes mellitus ( type or type 2).
• 2)Age ≥ 18 years.
• 3)Able and willing to provide informed consent.
• 4. Definite retinal thicking due to diabetic macular edema based on clinical examination involving the centre of the macula.
• 5. Media clarity, papillary dilatation, and patient cooperation sufficient For adequate fundus photographs.
• 6. IOP < 25 mmHg.

Exclusion Criteria

• 1)History of chronic renal failure requiring dialysis or kidney transplant.
• 2)Known allergy to any corticosteroid or any component of the delivery vehicle.
• 3)History of systemic (e.g. oral, IV, IM, epidural, bursal) corticosteroids within 4 ) months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week.
• 5)Proliferative diabetic retinopathy.
• 7)Intraocular pressure ≥ 25 mmHg. 8)History of open angle glaucoma.
• 9)History of steroid-induced intraocular pressure elevation that required IOP lowering agents.
• 10)History of prior treatment with intravitreal corticosteroids within 6 months prior to randomization.
• 11)History of focal/grid macular photocoagulation within 15 weeks (3.5 months) prior to randomization.
• 12)History of panretinal scatter photocoagulation (PRP) within prior 4 months or anticipated within the next 6 months following randomization.
• 14)History of prior herpetic ocular infection.
• 15)An ocular condition is present such that visual acuity would not improve from resolution of macular edema (e.g. foveal atrophy, pigmentary changes, nonretinal conditions).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bestcorrecterd Visual Acuity and	Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24
Intraocular pressure	Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24

Secondary Outcome Measures

Name	Time	Method
any Adverse events	Day 1, Day 7, Weeks 3, Weeks 6, Weeks 12, Weeks 24

Trial Locations

Locations (1)

Department of Ophthalmology, Sir Takhatsinhji general Hospital , Bhavnagar; 🇮🇳 Bhavnagar, GUJARAT, India

Department of Ophthalmology, Sir Takhatsinhji general Hospital , Bhavnagar

🇮🇳Bhavnagar, GUJARAT, India

Dr Hetal Patel

Principal investigator

9099987070

drhetalpatel@ymail.com