A Phase 3 interventional study of Active laser photocoagulation and Sham injections in Visual Impairment Due to Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals. Terminated at 36 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-30.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
This study was designed to confirm the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in patients with visual impairment due to Diabetic Macular Edema. A subgroup of patients with Proliferative Diabetic Retinopathy were included to evaluate the efficacy and safety of laser photocoagulation as adjunctive therapy to ranibizumab 0.5 mg versus laser monotherapy in this population.
308 studies on the registry are indexed under Vision Disorders; 81 are open to participants now.
This study's enrollment of 128 is above the median of 66 across 211 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
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Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Ranibizumab intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Procedure: Active laser photocoagulation · Drug: Ranibizumab 0.5 mg
Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment. Sham intravitreal injection given at baseline, at 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Procedure: Active laser photocoagulation · Drug: Sham injections
Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12
Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
Time frame: 12 months
Participants did not complete study due to early termination. Study was terminated because of drug approval.
| Milestone | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection |
|---|---|---|
| Started | 85 | 43 |
| Completed | 0 | 0 |
| Not completed | 85 | 43 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Abnormal laboratory value | 1 | 0 |
| Withdrew: Unsatisfactory therapeutic effect | 0 | 3 |
| Withdrew: Protocol violation | 2 | 1 |
| Withdrew: Withdrawal by subject | 3 | 3 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Administrative problems | 1 | 1 |
| Withdrew: Study termination | 78 | 32 |
Mean change in Best-Corrected Visual Acuity (BCVA) letters at 12 months compared to baseline was measured using Visual acuity (VA). VA accounts for the number of letters a participant can see using Early Treatment Diabetic Retinopathy Study (EDTRS)-like visual acuity testing charts, from a sitting position at a testing distance of 4 meters. BCVA means that the participant's refraction is already taken into account when VA is determined. A higher BCVA number at 12 months in reference to baseline indicates improved BCVA.
| Letters | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection |
|---|---|---|
| Change in Best-Corrected Visual Acuity (BCVA) From Baseline to Month 12 | 6.5 ± 8.6 | 1.4 ± 7.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active Laser Photocoagulation and Ranibizumab | — | 14/85 (16.5%) | 32/85 (37.6%) |
| Active Laser Photocoagulation and Sham Injection | — | 5/43 (11.6%) | 10/43 (23.3%) |
| Event | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection |
|---|---|---|
| RETINAL DETACHMENT (Fellow eye)Eye disorders | 0/85 | 2/43 |
| HYPOGLYCAEMIAMetabolism and nutrition disorders | 2/85 | 0/43 |
| CORONARY ARTERY DISEASECardiac disorders | 0/85 | 1/43 |
| CORONARY ARTERY STENOSISCardiac disorders | 0/85 | 1/43 |
| VITREOUS HAEMORRHAGE (Fellow eye)Eye disorders | 0/85 | 1/43 |
| CONCOMITANT DISEASE PROGRESSIONGeneral disorders | 0/85 | 1/43 |
| TYPE 1 DIABETES MELLITUSMetabolism and nutrition disorders | 0/85 | 1/43 |
| CHONDROPATHYMusculoskeletal and connective tissue disorders | 0/85 | 1/43 |
| OSTEOARTHRITISMusculoskeletal and connective tissue disorders | 0/85 | 1/43 |
| CARDIAC FAILURE CONGESTIVECardiac disorders | 1/85 | 0/43 |
| Event | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection |
|---|---|---|
| EYE PAIN (Study eye)Eye disorders | 13/85 | 4/43 |
| NASOPHARYNGITISInfections and infestations | 13/85 | 6/43 |
| HYPERTENSIONVascular disorders | 4/85 | 4/43 |
| EYE IRRITATION (Study eye)Eye disorders | 5/85 | 0/43 |
| LACRIMATION INCREASED (Study eye)Eye disorders | 5/85 | 1/43 |
| HEADACHENervous system disorders | 5/85 | 1/43 |
| Age Continuous(years) | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection | Total |
|---|---|---|---|
| >=18 years | 63.5 ± 9.3 | 63.5 ± 10.5 | 63.5 ± 9.7 |
| Sex: Female, Male(Participants) | Active Laser Photocoagulation and Ranibizumab | Active Laser Photocoagulation and Sham Injection | Total |
|---|---|---|---|
| Female | 32 | 16 | 48 |
| Male | 53 | 27 | 80 |
This study is terminated, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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