Health Condition 1: H358- Other specified retinal disorders
Conditions
Interventions
Intervention1: Lamivudine: oral tablet - 150mg twice daily for 6 months,
at the end of weeks 4,8 and 12, participants will receive loading doses of intravitreal Avastin
Control Intervention1: placebo:
Sponsors
Aravind Eye Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Patient age of 18 years or older 1)BCVA of = 24 and = 73 letters (20/40 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400 Snellen equivalent) 2)Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy. Any one of the following will be considered sufficient evidence that diabetes is present: Current regular use of insulin for the treatment of diabetes Current regular use of oral hypoglycemic agents for the treatment of diabetes 3)DME based on investigator’s clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and/or spectral domain-optical coherence tomography (SD - OCT) 4)Mean foveal thickness of at least 325 µm by SD - OCT 5)Ability and willingness to comply with the treatment and follow up procedures 6)Ability to understand and sign the informed consent form 7)Intraocular pressure of = 21 mm Hg on 2 or fewer IOP lowering medications
Exclusion criteria
Exclusion criteria: 1)Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc. 2)Body weight less than 55 kg 3)Allergy or hypersensitivity (known or suspected) to fluorescein or any component of the investigational product or delivery system 4)Any ocular surgery in the study eye within 12 weeks of screening 5)Any history of vitrectomy in the study eye 6)Aphakia in the study eye 7)Presence of severe foveal ischemia 8)Prior intraocular or periocular treatment for Diabetic macular edema 9)Macular laser for the treatment of diabetic macular edema within 12 weeks of screening 10)Any change in systemic steroidal therapy within 3 months of screening 11)Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy 12)History or presence of viral disease of the cornea or conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, any mycobacterial infections of the eye, or any fungal disease of any ocular structure or history of infectious retinitis 13)History or presence of any disease or condition that in the investigator’s opinion would preclude study treatment or follow-up or that in the opinion of the investigator would render them as unlikely to benefit from study treatment 14)Any lens or corneal opacity which impairs visualization of the posterior pole 15)Participation in another clinical trial within 12 weeks before the screening visit or during the study 16)History of any clinically significant medical disorders the principal investigator considers exclusionary, including (but not limited to), neuromuscular, hematological disease, immune deficiency state, respiratory disease, hepatic or gastrointestinal disease, neurological or psychiatric disease, neoplastic disease, renal or urinary tract diseases, or dermatological disease 17)History or current evidence of hypersensitivity to any components of the study medication, as assessed by the investigator 18)Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active ingredient (whichever is longer) prior to the start of study treatment. Clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary 19)Expectation that subject will be moving away from the area of the clinical treatment center without the ability to return for visits within the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline in Best-corrected visual acuity assessed with Early treatment diabetic retinopathy study (ETDRS) visual acuity testing chartTimepoint: at baseline and weeks 4,8,12,16,20 and 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline Center Subfield Macular Thickness (CMT). Assessed with Spectral Domain Optical Coherence Tomography (SD-OCT)Timepoint: at baseline and Weeks 4, 8, 12, 16, 20 and 24;Change from baseline in Foveal Avascular Zone (FAZ) and Vessel Density (VD) Assessed with Optical Coherence Tomography Angiography (OCTA)Timepoint: at baseline and Weeks 4, 8, 12, 16, 20 and 24 | — |
Countries
India
Contacts
Public ContactDr Siddharth Narendran
Aravind Eye Hospital, Coimbatore
Outcome results
None listed